©Nutriset2014 All rights reserved
Transcription
©Nutriset2014 All rights reserved
©Nutriset2014 All rights reserved Who is this booklet intended for? This document is addressed to logisticians, procurement, program and nutrition officers working in country/regional offices or headquarters of national/international organizations, donor agencies or ministries. Why such a booklet? The objective of this booklet is to provide humanitarian and social stakeholders with all the necessary information about Plumpy’Nut to successfully procure and integrate this product into their nutrition programs. How is it structured? The first chapter provides a description of the product, its context and concept. Chapters 2 and 3 detail the product’s ingredients, nutritional value, and give information for use (recommended dosage, duration and use). Quality and packaging considerations are discussed in the subsequent chapters 4 and 5. Product-related studies and references are given to explain the scientific evidences supporting the use of Plumpy’Nut today. Finally, this booklet provides answers to “Frequently Asked Questions.” Plumpy’Nut® is a registered trademark of Nutriset, patent IRD/Nutriset. Plumpy’Soy™ and Plumpy’Sup™ are Nutriset products trademarks. 2 INDEX 1 PRODUCT DESCRIPTION..................................................................................................................4 1.1 Short description..........................................................................................................................4 1.2 Context (nutrition issue and determinants)..................................................................................4 1.3 Background of product development...........................................................................................4 1.4 Product concept and benefit........................................................................................................5 1.5 Context of use...............................................................................................................................6 2 INGREDIENTS AND NUTRITIONAL VALUE........................................................................................7 2.1 Ingredients....................................................................................................................................7 2.2 Nutrition facts...............................................................................................................................8 3 RECOMMENDED DOSAGE, DURATION & USE.................................................................................9 3.1 Target group.................................................................................................................................9 3.2 Recommended daily dose.............................................................................................................9 3.3 Duration of treatment..................................................................................................................9 3.4 Recommendations for use..........................................................................................................10 4 QUALITY CONSIDERATIONS..........................................................................................................11 4.1 Raw materials and packaging .....................................................................................................11 4.2 Quality Control ...........................................................................................................................11 4.3 Traceability ................................................................................................................................12 4.4 Certificates .................................................................................................................................12 4.5 Stability, Best Before Date (BBD) ...............................................................................................13 4.6 Conservation and storage...........................................................................................................13 5 PACKAGING CONSIDERATIONS.....................................................................................................14 5.1 Primary packaging design...........................................................................................................14 5.2 Technical and legal information on primary packaging..............................................................14 5.3 Secondary packaging design.......................................................................................................15 5.4 Technical and legal information on secondary packaging..........................................................15 5.5 Leaflet ........................................................................................................................................16 6 EVIDENCE SUPPORTING THE USE OF PLUMPY’NUT.......................................................................17 6.1 Finalized studies.........................................................................................................................17 6.2 Where Plumpy’Nut has been distributed...................................................................................27 6.3 Related references......................................................................................................................27 7 PRODUCTION ...............................................................................................................................31 7.1 Global Production.......................................................................................................................31 7.2 Local Production.........................................................................................................................31 8 FAQs.............................................................................................................................................34 3 1 1.1 PRODUCT DESCRIPTION Short description Plumpy’Nut is a Ready-to-Use food, especially designed for the nutritional rehabilitation of severe acute malnutrition in children over 6 months of age. Plumpy’Nut corresponds to the definition of “RUTF” (Ready-to-Use Therapeutic Food) that can be found in scientific literature related to the treatment of severe acute malnutrition. 1.2 Context (nutrition issue and determinants) During the first years of life, children living in developing countries are most at risk of undernutrition. It is crucial to correct the nutritional status in these young age groups as soon as possible because it is an important period of growth and development. Malnutrition has a direct impact on the physical and psychological development of individuals, and acute malnutrition, the most serious degree of malnutrition, is associated with an increased risk of morbidity and infant mortality. 1.3 Background of product development Since the 1990s, the management of severe acute malnutrition has been conducted using therapeutic milks (F-75 for stabilization and F-100 for catch-up growth). Therapeutic milk powder can only be used in therapeutic feeding centres (TFCs) where its safe preparation and utilization is ensured by a close supervision. Milk powder has to be diluted with potable water (boiled if necessary) and consumed within a limited time period to constrict bacterial growth. To ensure a more practical way of treating severe acute malnutrition Plumpy’Nut was developed in 1996, as a Ready-to-Use Therapeutic Food with the same nutritional value as the F-100. Because it can be used at home without any preparation, under the supervision of the mother or another member of the family, Plumpy’Nut® makes it possible to treat the majority of children suffering from severe acute malnutrition without hospitalization. 4 1.4 Product concept and benefit Children who fall under the cut-off for severe acute malnutrition (using Mid Upper Arm Circumference, Weight for Height measurement, and/or the presence of nutritional oedema) need to receive an adapted diet that allows them to regain a normal nutritional status. The diet needs to account for a malnourished child’s elevated nutrient and energy requirements for catch-up growth. Because Plumpy’Nut does not need to be mixed with water and has shown to be resistant to bacterial contamination due to its low water activity 7,1 its invention induced a deep change in the management of acute malnutrition by making outpatient care possible for acutely malnourished children with appetite and without medical complications. Home treatment with only weekly supervision reduces the burden on the families (opportunity costs) as well as the costs of TFC management, while increasing treatment coverage. 2,3,4,5,6,7,8 1Briend A “Highly nutrient-dense spreads: a new approach to delivering multiple micronutrients to high risk groups.” Br J Nutr (2001); 85: S175-179. 2Collins S and Sadler K. “0utpatients care for severely malnourished children in emergency relief programmes: a retrospective cohort study.” The Lancet (2002); 360:1824-30. 3Collins S. “Changing the way we address severe malnutrition during famine.” The Lancet (2001); 358:498-501. 4Collins S. “Ambulatory treatment of severe malnutrition.” Field Exchange, (July 2003) Issue 19. 5Nestel P et al. “Complementary Food Supplements to achieve Micronutrient Adequacy for infants and young children.” Extract. J Pediatr Gastroenterol Nut (2003); 36:346-328. 6Manary MJ et al. “Home based therapy for severe malnutrition with ready-to-use food.” Arch Dis Child (2004); 89: 557-61. 7Ciliberto MA. “Home-based therapy for oedematous malnutrition with ready-to-use therapeutic food.” P. Acta Paediatr (2006), 95:1012-5. 8Briend A et al. “Ready-to-Use therapeutic food for treatment of marasmus.” The Lancet (1999); 353:1767-8. 5 1.5 Context of use The diagram below shows how Plumpy’Nut is used within the various intervention programs. Figure 1 : Plumpy’Nut® used in phase 2 of therapeutic care of patients suffering from severe acute malnutrition As shown in figure 1, Plumpy’Nut is used during the nutritional rehabilitation phase (phase 2) in CMAM (Community-Based Management of Acute malnutrition) programs. As shown by Diop et al (2003) when comparing it to F-100, Plumpy’Nut is not only preferred by children, it also holds a much lower risk of contamination and severely malnourished children consuming it show higher weight gains than those receiving F-100 therapeutic milk. 9 However therapeutic milk F-100 is still the product of reference when it comes to treat severely acutely malnourished children that have medical complications. Several studies have demonstrated that Plumpy’Nut is efficacious in treating severe as well as moderate acute malnutrition.9,10 In order to improve cost effectiveness of the treatment, other products dedicated to the treatment of moderate acute malnutrition have been developed (for more information, please refer to booklet for Plumpy’Sup). 9Diop el HI et al. “Comparison of the efficacy of solid ready-to-use and a liquid, milk-based diet for the rehabilitation of severely malnourished children: a randomised trial.” Am J Clin Nutr (2003); 78:307-7. 10Ciliberto MA et al. “Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial.” Am J Clin Nutr (2005); 81, 864–870. 6 2 2.1 INGREDIENTS AND NUTRITIONAL VALUE Ingredients Plumpy’Nut is made out of peanuts, non-hydrogenated vegetable fat (palm, rapeseed), sugar, skimmed milk powder, whey powder, maltodextrin (wheat or corn), vitamin and mineral complex, emulsifiers: vegetable lecithin (soy or sunflower), mono and diglycerides, and stabilizers: hydrogenated vegetable fat. Plumpy’Nut contains the following potential allergens: peanuts, milk and milk products. Plumpy’Nut may also contain traces of soy. Plumpy’Nut does not contain any Genetically Modified Organism (GMO). It does not contain any ingredients of animal origin, except dairy products. Note: Plumpy’Nut is a paste of light brown to orange brown colour, with typical flavour and odour of peanut and milk. 7 2.2 Nutrition facts For 100g of Plumpy’Nut Energy Proteins (% of total energy ) Proteins Min Max For 92 g (serving size) 520 kcal 550 kcal 500 kcal 10% of energy 12% of energy 13 g 50 % of total % of milk proteins proteins For 100g of Plumpy’Nut Min Max For 92 g (serving size) Iron 10 mg 14 mg 10,6 mg 10% of energy Iodine 70 µg 140 µg 92 µg 16 g 12.1 g Selenium 20 µg 40 µg 27.6 µg - > 50 % of total proteins Sodium - 290 mg < 267 mg Vitamin A 800 µg 1200 µg 840 µg PDC AAS ( P r o t e in D ig e s t ib ilit y C o r r e c t e d A m in o A c id S c o r e ) Lipids (% of total energy ) Lipids Fatty acid n-6 > 0.95 - 1 45% of energy 60% of energy 56% of energy Vitamin D 15 µg 20 µg 15 µg 26 g 36 g 29.9 g Vitamin E 20 mg 40 mg 18,4 mg 3% of energy 10% of energy ≈7% Vitamin C 50 mg 132 mg 49 mg Vitamin B1 0,5 mg 1,5 mg 0,55 mg Vitamin B2 1,6 mg 3,0 mg 1,66 mg (= 4 g) (% of total energy ) Fatty acid n-3 ≈ 0.7 % 0.3% of energy 2.5% of energy (= 0.35 g) (% of total energy ) 45 g C arbohy drates 41 g 58 g Fibre content - < 5% < 5% Vitamin B6 0,6 mg 0,9 mg 0,55 mg M oisture - 2.5 % 2.5 % Vitamin B12 1,6 µg 3,0 µg 1.7 µg C alcium 300 mg 500 mg 276 mg Vitamin K 15 µg 30 µg 19,3 µg Phosphorus 300 mg 500 mg 276 mg Biotin 60 µg 90 µg 60 µg Potassium 1100 mg 1400 mg 1022 mg Folic acid 200 µg 400 µg 193 µg M agnesium 80 mg 100 mg 84,6 mg Pantothenic acid 3 mg 6 mg 2,85 mg Zinc 11 mg 14 mg 12,9 mg N iacin 5 mg 9 mg 4,88 mg C opper 1,4 mg 1,8 mg 1,6 mg (≈ 36% of total energy ) Note: Trans fatty acids < 3% of total fatty acids Plumpy’Nut complies with the specifications set in UN Agencies’ joint statement «Community-based management of severe acute malnutrition» published in May 2007 11. 11Community-based Management of Severe Acute Malnutrition A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children’s Fund, May 2007. 8 3 RECOMMENDED DOSAGE, DURATION & USE 3.1 Target group 1) Primary target group: Children 6 - 59 months of age suffering from Severe Acute Malnutrition 12 2) Secondary target group: 3.2 Children 6-59 months of age suffering from Moderate Acute Malnutrition Adults suffering from severe acute malnutrition 13 Recommended daily dose Inpatient transition phase: - after stabilisation with F-75 when moving to rehabilitation: 100 - 135 kcal/kg body weight / day (for 2-3 days before complete transition to outpatient care) Outpatient treatment: 200 kcal/kg body weight /day (>130 kcal/kg body weight / day)* Providing about all of the child’s energy and nutrient requirements in addition to breast milk. Recommended quantities of Plumpy’Nut Severe Acute Malnutrition Moderate Acute Malnutrition 200 kcal / kg body weight / day 75kcal / kg body weight/ day the standard regimen is 2 sachets per day for a child between 5 and 6.9 kg, 3 sachets for a child between 7 and 9.9 kg and 4 sachets for a child more than 10 kg That is about 1 sachet per day for a moderately acutely malnourished child weighting 7 kg *Recommended amount of energy and nutrients according to WHO protocol for the treatment of severe malnutrition with F-100 therapeutic milk.14 3.3 Duration of treatment Nutritional treatment is necessary until the child reaches the discharge criteria (e.g. MUAC) and is considered recovered 13, which may take from 4 to 10 weeks, depending on the programme’s context and performance. 12Diop el HI et al. “Home-based rehabilitation for Severely Malnourished Children Using Locally Made Ready-to-Use Therapeutic Food (RUTF)” Reports from the 2 nd World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition. Paris (France), (July 3-7, 2004). Medimond, Monduzzi Editore (international Proceedings) pp. 101-105. 13Navarro-Colorado C et al. “Comparison of a liquid and solid diet for the rehabilitation of severely malnourished adults: a clinical trial.” Submitted to the European Journal of Clinical Nutrition 14WHO. "Management of severe malnutrition: a manual for physicians and other senior health workers". 1999 9 3.4 Recommendations for use Plumpy’Nut has to be prescribed and initiated by trained health and nutrition professionals only. Severely malnourished children are treated under medical supervision. Medical supervision can be provided as inpatient or outpatient care. Severely malnourished children treated with Plumpy’Nut should receive regular check-ups by a health practitioner prior to receiving their next ration of Plumpy’Nut. Plumpy’Nut is a ready to use therapeutic food (RUTF) and can be consumed directly from the sachet without prior cooking, or dilution with water. The product can easily be opened by tearing off one corner of the sachet The sachets of Plumpy’Nut can be used by a child on their own, without any assistance. After opening, the sachet has to be consumed within 24 hours. Plumpy’Nut should not be given to people who are allergic to cow milk or peanuts. Plumpy’Nut is not likely to increase the child’s need for water 15, but it is recommended to have potable water available for the child when consuming Plumpy’Nut. Plumpy’Nut should not be shared with other people in the family, because it could reduce the amount the child would consume, which may no longer be sufficient to satisfy the child’s needs. Plumpy’Nut is not adapted for well-nourished children nor adults. The use of Plumpy’Nut should be limited to the treatment of malnutrition. Plumpy’Nut must not replace breastfeeding. Children under 2 years of age receiving Plumpy’Nut should continue to receive breastmilk. Breastfeeding is recommanded for at least 24 months, and exclusively for the first 6 months of age. 15Collins S and Sadler K. “0utpatients care for severely malnourished children in emergency relief programmes: a retrospective cohort study.” The Lancet (2002); 360:1824-30. 10 4 QUALITY CONSIDERATIONS The Quality Management System set up by Nutriset is based on International standards (ISO 22 000:2005) and Recommendations of Codex Alimentarius (HACCP method). 4.1 Raw materials and packaging Plumpy’Nut is packaged under protective atmosphere in order to optimize the product’s shelf life, and sachets are air and humidity tight. Plumpy’Nut complies with the “Guidelines for Formulated Supplementary Foods for Older Infants and Young Children” of the Codex Alimentarius CAC/GL 08-1991. All added mineral salts and vitamins included in Plumpy’Nut are on the “Advisory Lists of Nutrient Compounds for Use in Foods for Special Dietary Uses intended for Infants and Young Children” of the Codex Alimentarius Standard CAC/GL 10-1979 (amended 1983, 1991, 2009). All raw materials are “food grade” in compliance with general recommendations of Codex Alimentarius (STAN 200-1995, STAN 207-1999, STAN 212-1999). Packaging material of the sachet is suitable for food contact according to European Regulation 1935/2004, 27th October 2004. 4.2 Quality Control Plumpy’Nut complies with the microbiological criteria recommended by the document «Community-based management of severe acute malnutrition»16 and/or the « Arrêté du 1 juillet 1976 relatif aux aliments destinés aux nourrissons et aux enfants en bas âge, version consolidée au 26 février 2005 » from French regulations. A Quality Control Plan is defined for Plumpy’Nut, including analyses and tests of raw material/ packaging and end product: Bacteriological analyses (Salmonella, Enterobacteriaceae, Total count plate, E. coli, Staphylococcus aureus, anaerobic sulfito-reductor, Yeast, Moulds, Listeria, Cronobacter sakazakii…) ; Chemical analyses (Proteins, Lipids, Chlorides, vitamin C…) ; Physical analyses (odour, colour, taste…) ; Checks on production line (leaks, printing…). 16UNICEF, WHO, WFP, UNSCN. “Community-based management of severe acute malnutrition, A Joint Statement.” 2007 11 4.3 Traceability The Quality management system guarantees up- and downstream traceability of Plumpy’Nut: The batches of raw materials used, as well as further information related to the production (equipment used, production operators…) can be tracked back from the end product. From a batch of raw materials, it is possible to identify the batches of manufactured end products and their destination. For Nuriset, a batch mark corresponds to one day of production while it is one week for the PlumpyField members. The batch number is defined as follow: 4.4 Certificates Nutriset can supply various documents related to a particular batch: Certificate of analysis: summarizes the results of analysis that allowed the release of the batch. Methods of analysis are described. Certificate of conformity: clarifies the criteria and specifications related to the product. Health and non-radioactivity certificates can be issued from the information communicated by the raw material suppliers. Others certificates can be provided upon request (Non-GMO certificate, certificate of origin...) 12 4.5 Stability, Best Before Date (BBD) The best before date (BBD) of Plumpy’Nut is based on Nutriset’s research since the late 1990’s and guarantees physicochemical stability and the content of each specified nutrient for 24 months from the date of manufacture. A vitamin and mineral premix has been formulated for Plumpy’Nut. The level of each element has been defined according to their individual stability during storage to ensure Plumpy’Nut specifications. Plumpy’Nut ingredients include technological additives that guarantee the physical stability of the product (no oil separation), and its organoleptic and nutritional properties during storage. Sachets are sealed under nitrogen atmosphere, to limit oxidation. Best before date (« BB ») is 24 months from the manufacturing date stated on each sachet. 4.6 Conservation and storage Plumpy’Nut should be stored in a dry and cool place, at a temperature below 30°C (86°F), away from direct sunlight. Reducing the Best Before date by 1/3 is recommended when storage temperature is between 30 and 40°C, and by half when storage temperature is over 40°C. It is recommended not to stack the pallets. 13 5 5.1 PACKAGING CONSIDERATIONS Primary packaging design In order to facilitate distribution, use and understanding of the product in the field, key messages related to the product have been defined. Visual aids such as pictograms help to convey these messages: 5.2 Technical and legal information on primary packaging Each sachet contains 92 g and provides 500 kcal. All technical and legal information is indicated on the sachet, in 3 languages (French, English and Spanish): 14 Name of the product Target List of ingredients Net weight Kilocalories content Name and address of the manufacturer Batch identification, Production date and Best Before date Storage instructions Instructions for use 5.3 Secondary packaging design The same key messages (and visual aids) appear on the carton. The shipping cartons are designed to withstand long transport times and multiple handlings. Their size was chosen to optimize the various possible kinds of shipment. 5.4 Technical and legal information on secondary packaging The following technical and legal information is indicated on the carton, in 3 languages (French, English and Spanish): Name of the product Target Estimated net weight and gross weight of the carton Approximate number of sachets per carton, and kilocalories per sachet 15 Storage instructions Instructions for use Name and address of the manufacturer Batch identification, Production date and Best Before date 5.5 Leaflet The following technical and legal information is indicated on a separate leaflet present in every secondary packaging, in 3 languages (French, English and Spanish): Detailed nutritional information Target Instructions for use Recommended dosage Storage instructions List of ingredients Mean nutritional value Name, address and contact details of the manufacturer 16 6 6.1 EVIDENCE SUPPORTING THE USE OF PLUMPY’NUT Finalized studies Please find below a non-exhaustive list of references: Acceptability of Plumpy’Nut Briend A et al. “Ready-to-use therapeutic food for treatment of marasmus.” Lancet (1999); 353: 1767-8. Dube B et al. "Comparison of Ready-to-Use Therapeutic Food with Cereal Legume-based Khichri Among Malnourished Children”, Indian Paediatrics (2009); 46:383-8 Objective: To compare the acceptability and energy intake of Ready-to-Use Therapeutic Food (RUTF) with cereal legume based khichri among malnourished children. Subjects: 31 children aged ≥6 to ≤36 months with malnutrition, defined as Weight for height (WHZ) <–2 to ≥–3 SD, with no clinical signs of infection or edema. Intervention: Children were offered weighed amounts of RUTF and khichri in unlimited amounts for 2 days, one meal of each on both days. Water was fed on demand. Caregivers’ interviews and observations were conducted on the second day. Outcome Measures: Acceptability of RUTF compared to khichri based on direct observation and energy intake for test and control meals. Results: The proportion of children who accepted RUTF eagerly was 58% as against 77% for khichri. 42% children on RUTF and 23% on khichri accepted the meal but not eagerly. The median (IQR) energy intake over the two day period in children aged 6 to 36 months from RUTF was 305 (153, 534) kcal, and from khichri was 242 (150, 320) kcal (P=0.02). Conclusion: RUTF and khichri were both well accepted by study children. The energy intake from RUTF was higher due to its extra energy density. Nga TT et al. Acceptability and impact on anthropometry of a locally developed ready-to-use therapeutic food in pre-school children in Vietnam. Nutr J. 2013; 12:120. BACKGROUND: In South East Asia, concerns exist about the acceptability of peanut-based Readyto-Use-Therapeutic-Foods (RUTF) for the treatment of severe acute malnutrition (SAM). Therefore, an alternative, culturally acceptable RUTF made from locally available ingredients and complying with local food traditions and preferences was developed. The current study evaluated its acceptability and impact on anthropometry. METHODS: The study was a randomized, two-arm, cross-over intervention trial to test the acceptability of the local product (bar) against a commercially available, peanutbased RUTF paste (Plumpy'nut). Children (n = 67) from two kindergartens in a rural area of North Vietnam were recruited. The age of the children was between 3 and 5 years. RESULTS: The Vietnamese RUTF was well-accepted, although overall acceptability was less than of Plumpy'nut, with the latter scoring higher on palatability (P < 0.05). In contrast, reluctance to eat Plumpy'nut was higher than for the Vietnamese RUTF (P < 0.05). Impact on anthropmetrical indices was similar for both RUTF. The nutritional status of the children who consumed the twoRUTF over a 4 week period improved significantly, with a mean weight gain of 0.64 (SD 0.27) Kg, and increases in WHZ and HAZ z-scores of 0.48 (SD 0.30) and 0.05 (SD 0.13) respectively (P < 0.01 both). Weight gain was similar between the 2 products (0.32 kg per 2 weeks for both). 17 CONCLUSIONS: Both the commercial Plumpy'nut and the local produced RUTF were accepted although the harder consistency of the local product might have caused the lower overall acceptance. The promising increase in nutritional status needs to be confirmed in a controlled trial in children with SAM Efficacy trials of Plumpy’Nut in hospital settings Diop el HI et al. “Comparison of the efficacy of a solid ready-to-use food and a liquid, milkbased diet for the rehabilitation of severely malnourished children: a randomized trial.” Am J Clin Nutr. (2003); 78: 302-7. Background: The World Health Organization recommends a liquid, milk-based diet (F100) during the rehabilitation phase of the treatment of severe malnutrition. A dry, solid, ready-to-use food (RTUF) that can be eaten without adding water has been proposed to eliminate the risk of bacterial contamination from added water. The efficacies of RTUF and F100 have not been yet compared. Objective: The objective was to compare the efficacy of RTUF and F100 in promoting weight gain in malnourished children. Design: In an open-labelled, randomized trial, 70 severely malnourished Senegalese children aged 6-36 mo were randomly allocated to receive 3 meals containing either F100 (n = 35) or RUTF (n = 35) in addition to the local diet. The data from 30 children in each group were analyzed. Results: The mean (+/- SD) daily energy intake in the RTUF group was 808 +/- 280 (95% CI: 703.8, 912.9) kJ x kg body wt(-1) x d(-1), and that in the F100 group was 573 +/- 201 (95% CI: 497.9, 648.7) kJ. kg body wt(-1) x d(-1) (P < 0.001). The average weight gains in the RTUF and F100 groups were 15.6 (95% CI: 13.4, 17.8) and 10.1 (95% CI: 8.7, 11.4) g x kg body wt(-1) x d(-1), respectively (P < 0.001). The difference in weight gain was greater in the most wasted children (P < 0.05). The average duration of rehabilitation was 17.3 (95% CI: 15.6, 19.0) d in the F100 group and was 13.4 (95% CI: 12.1, 14.7) d in the RTUF group (P < 0.001). Conclusions: This study indicated that RTUF can be used efficiently for the rehabilitation of severely malnourished children. Efficacy & effectiveness of Plumpy’Nut in the community Ashworth A. “Efficacy and effectiveness of community-based treatment of severe malnutrition.” Food Nutr. Bull. (2006); 27:S24-48. Background. There is a long tradition of community based rehabilitation for treatment of severe malnutrition: the question is whether it is effective and whether it should be advised for routine health systems. Objective. To examine the effectiveness of rehabilitating severely malnourished children in the community in nonemergency situations. Methods. A literature search was conducted of community-based rehabilitation programs delivered by day-care nutrition centers, residential nutrition centers, primary health clinics, and domiciliary care with or without provision of food, for the period 1980–2005. Effectiveness was defined as mortality of less than 5% and an average weight gain of at least 5 g/kg/day. Results. Thirty-three studies of community-based rehabilitation were examined and summarized. Eleven (33%) programs were considered effective. Of the subsample of programs reported since 1995, 8 of 13 (62%) were effective. None of the programs operating within routine health systems without external assistance was effective. 18 Conclusions. With careful planning and resources, all four delivery systems can be effective. It is unlikely that a single delivery system would suit all situations worldwide. The choice of a system depends on local factors. High energy intakes (> 150 kcal/kg/day), high protein intakes (4–6 g/kg/day), and provision of micronutrients are essential for success. When done well, rehabilitation at home with family foods is more cost-effective than inpatient care, but the cost effectiveness of ready-to-use therapeutic foods (RUTF) versus family foods has not been studied. Where children have access to a functioning primary health-care system and can be monitored, the rehabilitation phase of treatment of severe malnutrition should take place in the community rather than in the hospital but only if caregivers can make energy- and protein-dense food mixtures or are given RUTF. For routine health services, the cost of RUTF, logistics of procurement and distribution, and sustainability need to be carefully considered. Ciliberto MA. “Home-based therapy for oedematous malnutrition with ready-to-use therapeutic food.” P. Acta Paediatr. (2006); 95:1012-5. Background: Standard recommendations are that children with oedematous malnutrition receive inpatient therapy with a graduated feeding regimen. Aim: To investigate exclusive home-based therapy for children with oedematous malnutrition. Methods: Children with oedematous malnutrition, good appetite and no complications were treated at home with ready-to-use therapeutic food (RUTF) and followed up fortnightly for up to 8 wk. Setting and participants: 219 children aged 1-5 y with oedema enrolled in one of two therapeutic nutritional studies in Malawi in 2003-2004. Results: The overall recovery rate was 83% (182/219), and the case-fatality rate was 5% (11/219). For children with wasting and oedematous malnutrition, 65% (55/85) recovered and 7% (6/85) died. The average weight gain was 2.8+/-3.2 g/kg/d (mean+/-SD). Conclusion: This preliminary observation suggests that children with oedematous malnutrition and good appetite may be successfully treated with home-based therapy; a randomized, controlled trial to evaluate this is warranted. Ciliberto MA et al. “A comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial.” Am J Clin Nutr (2005); 81: 864-70. Background: Childhood malnutrition is common in Malawi, and the standard treatment, which follows international guidelines, results in poor recovery rates. Higher recovery rates have been seen in pilot studies of home-based therapy with ready-to-use therapeutic food (RUTF). Objectives: The objective was to compare the recovery rates among children with moderate and severe wasting, kwashiorkor, or both receiving either home-based therapy with RUTF or standard inpatient therapy. Design: A controlled, comparative, clinical effectiveness trial was conducted in southern Malawi with 1178 malnourished children. Children were systematically allocated to either standard therapy (186 children) or home-based therapy with RUTF (992 children) according to a stepped wedge design to control for bias introduced by the season of the year. Recovery, defined as reaching a weight-for-height z score > -2, and relapse or death were the primary outcomes. The rate of weight gain and the prevalence of fever, cough, and diarrhea were the secondary outcomes. Results: Children who received home-based therapy with RUTF were more likely to achieve a weight-for-height z score > -2 than were those who received standard therapy (79% compared with 46%; P < 0.001) and were less likely to relapse or die (8.7% compared with 16.7%; P < 19 0.001). Children who received home-based therapy with RUTF had greater rates of weight gain (3.5 compared with 2.0 g . kg(-1) . d(-1); difference: 1.5; 95% CI: 1.0, 2.0 g . kg(-1) . d(-1)) and a lower prevalence of fever, cough, and diarrhea than did children who received standard therapy. Conclusion: Home-based therapy with RUTF is associated with better outcomes for childhood malnutrition than is standard therapy. Collins S and Sadler K. “Outpatient care for severely malnourished children in emergency relief programmes: a retrospective cohort study.” Lancet (2002); 360: 1824-30. Background: In emergency nutritional relief programmes, therapeutic feeding centres are the accepted intervention for the treatment of severely malnourished people. These centres often cannot treat all the people requiring care. Consequently, coverage of therapeutic feeding centre programmes can be low, reducing their effectiveness. We aimed to assess the effectiveness of outpatient treatment for severe malnutrition in an emergency relief programme. Methods: We did a retrospective cohort study in an outpatient therapeutic feeding programme in Ethiopia from September, 2000, to January, 2001. We assessed clinical records for 170 children aged 6-120 months. The children had either marasmus, kwashiorkor, or marasmic kwashiorkor. Outcomes were mortality, default from programme, discharge from programme, rate of weight gain, and length of stay in programme. Findings: 144 (85%) patients recovered, seven (4%) died, 11 (6%) were transferred, and eight (5%) defaulted. Median time to discharge was 42 days (IQR 28-56), days to death 14 (7-26), and days to default 14 (7-28). Median rate of weight gain was 3.16 g kg(-1) x day(-1) (1.86-5.60). In patients who recovered, median rates of weight gain were 4.80 g kg(-1) day(-1) (2.95-8.07) for marasmic patients, 4.03 g x kg(-1) x day(-1) (2.68-4.29) for marasmic - kwashiorkor patients, and 2.70 g x kg(-1) x day(-1) (0.00-4.76) for kwashiorkor patients. Interpretation: Outpatient treatment exceeded internationally accepted minimum standards for recovery, default, and mortality rates. Time spent in the programme and rates of weight gain did not meet these standards. Outpatient care could provide a complementary treatment strategy to therapeutic feeding centres. Further research should compare the effectiveness of outpatient and centre-based treatment of severe malnutrition in emergency nutritional interventions. Diop EI et al. “Home-based Rehabilitation for Severely Malnourished Children Using Locally Made Ready-to-use Therapeutic Food (RUTF)” Reports from the 2nd World Congress of Pediatric Gastroenterology, Hepatology and Nutrition. Paris (France), July 3-7, 2004. Medimond, Monduzzi Editore (International Proceedings) pp. 101-105. Linneman Z. “A large-scale operational study of home-based therapy with ready-to-use therapeutic food in childhood malnutrition in Malawi.” Matern Child Nutr (2007); 3: 206 –15. Home-based therapy with ready-to-use therapeutic food (RUTF) for the treatment of malnutrition has better outcomes in the research setting than standard therapy. This study examined outcomes of malnourished children aged 6–60 months enrolled in operational homebased therapy with RUTF. Children enrolled in 12 rural centres in southern Malawi were diagnosed with moderate or severe malnutrition according to the World Health Organization guidelines. They were treated with 733 kJ kg−1 day−1 of RUTF and followed fortnightly for up to 8 weeks. Staff at each centre followed one of three models: medical professionals administered treatment (5 centres), patients were referred by medical professionals and treated by community health aids (4 centres), or community health aids administered treatment (3 centres). The primary outcome of the study was clinical status, defined as recovered, failed, died or dropped out. Regression modelling was conducted to determine what aspects of the centre (formal training of staff, location along a main road) contributed to the outcome. Of 2131 severely malnourished children and 806 moderately malnourished, 89% and 85% recovered, 20 respectively. Thirty-four (4%) of the moderately malnourished children failed, with 20 (2%) deaths, and 61 (3%) of the severely malnourished children failed, with 29 (1%) deaths. Centre location along a road was associated with a poor outcome. Outcomes for severely malnourished children were acceptable with respect to both the Sphere guidelines and the Prudhon case fatality index. Home-based therapy with RUTF yields acceptable results without requiring formally medically trained personnel; further implementation in comparable settings should be considered. Manary MJ. “Home based therapy for severe malnutrition with ready-to-use food.” Arch Dis Child. (2004); 89: 557-61. Background: The standard treatment of severe malnutrition in Malawi often utilises prolonged inpatient care, and after discharge results in high rates of relapse. Objectives: To test the hypothesis that the recovery rate, defined as catch-up growth such that weight-for-height z score >0 (WHZ, based on initial height) for ready-to-use food (RUTF) is greater than two other home based dietary regimens in the treatment of malnutrition. Methods: HIV negative children >1 year old discharged from the nutrition unit in Blantyre, Malawi were systematically allocated to one of three dietary regimens: RUTF, RUTF supplement, or blended maize/soy flour. RUTF and maize/soy flour provided 730 kJ/kg/day, while the RUTF supplement provided a fixed amount of energy, 2100 kJ/day. Children were followed fortnightly. Children completed the study when they reached WHZ >0, relapsed, or died. Outcomes were compared using a time-event model. Results: A total of 282 children were enrolled. Children receiving RUTF were more likely to reach WHZ >0 than those receiving RUTF supplement or maize/soy flour (95% v 78%, RR 1.2, 95% CI 1.1 to 1.3). The average weight gain was 5.2 g/kg/day in the RUTF group compared to 3.1 g/kg/day for the maize/soy and RUTF supplement groups. Six months later, 96% of all children that reached WHZ >0 were not wasted. Conclusions: Home based therapy of malnutrition with RUTF was successful; further operational work is needed to implement this promising therapy. Manary M et al. “Randomized, Double-Blind Controlled Clinical Effectiveness Trial Comparing a Novel 10% Milk Ready-to-Use Therapeutic Food with the Standard 25% Milk Ready-to-Use Therapeutic Food in the Treatment of Severe Acute Malnutrition in Rural Malawian Children.” (2009) Washington, DC: FANTA-2, Academy for Educational Development. Severe childhood malnutrition is defined as having a weight for height Z-score (WHZ) < -3 or bilateral pitting oedema. Standard therapy for cases of severe acute malnutrition without complications is home-based therapy with milk-peanut based RUTF. The cost of ingredients in RUTF limits its availability in resource-poor countries, with powdered milk constituting 67 percent of the cost. In this clinical effectiveness trial, severely malnourished children were given either a reduced milk formulation of RUTF (10 percent milk) in which milk was replaced with soy protein, or the standard formulation of RUTF (25 percent milk). Children received isocaloric quantities of the foods (733 kJ/kg/d) for up to eight weeks with biweekly follow up. The primary outcome was recovery, defined as having a WHZ of -2 and no oedema. A total of 1874 children were enrolled in the study. Children receiving 10 percent milk had a lower rate of recovery compared to those receiving the standard therapy (84 percent in the 25 percent milk group and 81 percent in the 10 percent milk group). Nonlinear regression modeling showed type of food to be a statistically significant term in rate of recovery. Overall, children who received the 10 percent milk formulation had slower rates of weight gain and slower MUAC gain. Differences of gain in stature were not statistically significant. Treating severely malnourished children with a 10 percent milk RUTF results in a lower rate of recovery and slower growth rates when compared to the standard 25 percent milk RUTF. 21 Navarro-Colorado C and McKenney P. “Home Based Rehabilitation of Severe Malnutrition vs. Inpatient care in a post-emergency setting. A Randomised Clinical Trial in Sierra Leone.” Draft Report. Oakley E et al. “A ready-to-use therapeutic food containing 10% milk is less effective than one with 25% milk in the treatment of severely malnourished children.” J Nutr. (2010); 140: 2248-52. Standard therapy for severe acute malnutrition (SAM) is home-based therapy with ready-to-use therapeutic food (RUTF) containing 25% milk. In an effort to lower the cost of RUTF and increase availability, some have suggested that a portion of milk be replaced with soy. This trial was designed to determine whether treating children with SAM with 10% milk RUTF containing soy would result in a similar recovery rate compared with the 25% milk RUTF. This was a randomized, double-blind, controlled, clinical, quasi-effectiveness trial of isoenergetic amounts of 2 locally produced RUTF to treat SAM in Malawi among children aged 6–59 mo. A total of 1874 children were enrolled. Children were assessed every fortnight and participated in the study until they clinically recovered or received 8 wk of treatment. The primary outcome was recovery (weightfor-height Z score > −2 and no edema). Secondary outcomes were rates of weight and height gain. Survival analysis was used to compare the recovery rates. Recovery among children receiving 25% milk RUTF was greater than children receiving 10% milk RUTF, 64% compared with 57% after 4 wk, and 84% compared with 81% after 8 wk (P < 0.001). Children receiving 25% milk RUTF also had higher rates of weight and height gain compared with children receiving 10% milk RUTF. Treating children with SAM with 10% milk RUTF is less effective compared with treatment with the standard 25% milk RUTF. These findings also emphasize that clinical evidence should be examined before recommending any changes to the formulation of RUTF. Sandige H et al. “Home-based treatment of malnourished Malawian children with locally produced or imported ready-to-use food.” J Pediatr Gastroenterol Nutr. (2004); 39: 141-6. Objectives: To determine the efficacy of home-based therapy with ready-to-use food (RTUF) in producing catch-up growth in malnourished children and to compare locally produced RTUF with imported RTUF for this purpose. Methods: After a brief inpatient stabilization, 260 children with severe malnutrition were enrolled and systematically allocated to receive home therapy with either imported, commercially produced RTUF or locally produced RTUF. Each child received 730 kJ/kg/day and was followed up fortnightly. Children completed the study when they reached a weight-forheight Z score > -0.5 (WHZ), relapsed, died, or failed to achieve WHZ > -0.5 after 16 weeks. Analyses were stratified by human immunodeficiency virus (HIV) status. Results: 78% of all children reached WHZ > -0.5, 95% of those with HIV-negative status and 59% of those with HIV-positive status. Eighty percent of those receiving locally produced RTUF and 75% of those receiving imported RUTF reached WHZ > -0.5. The difference between recovery rates was 5% (95% confidence interval [CI], -5-15%). The rate of weight gain was 0.4 g/kg/day (95% CI, -0.6, 1.4) greater among children receiving locally produced RTUF. The prevalence of diarrhea reported by mothers was 3.7% for locally produced RTUF and 4.3% for imported RTUF. After completion of home therapy and resumption of habitual diet for 6 months, 91% of all children maintained a normal WHZ. Conclusions: Home-based therapy with RTUF was successful in affecting complete catch-up growth. In this study, locally produced and imported RTUF were similar in efficacy in treating of severe childhood malnutrition. 22 Tectonidis M. “Crisis in Niger - Outpatient Care for Severe Acute Malnutrition.” N Engl J Med. (2006); 354:224-7. Available at: http://www.nejm.org/doi/full/10.1056/NEJMp058240 HIV-positive children Sunguya BF et al. “Ready To Use Therapeutic Food (RUTF) improves undernutrition among ART-treated, HIV-positive children in Dar es Salaam, Tanzania.” Nut J. (2012); 11:60. Available at: http://www.nutritionj.com/content/11/1/60 Background: HIV/AIDS is associated with an increased burden of undernutrition among children even under antiretroviral therapy (ART). To treat undernutrition, WHO endorsed the use of Ready to Use Therapeutic Foods (RUTF) that can reduce case fatality and undernutrition among ART-naïve HIVpositive children. However, its effects are not studied among ART-treated, HIV-positive children. Therefore, we examined the association between RUTF use with underweight, wasting, and stunting statuses among ART-treated HIV-positive children in Dar es Salaam, Tanzania. Methods: This cross-sectional study was conducted from September-October 2010. The target population was 219 ART-treated, HIV-positive children and the same number of their caregivers. We used questionnaires to measure socio-economic factors, food security, RUTFuse, and ART-duration. Our outcome variables were underweight, wasting, and stunting statuses. Results: Of 219 ART-treated, HIV-positive children, 140 (63.9%) had received RUTF intervention prior to the interview. The percentages of underweight and wasting among non-RUTFreceivers were 12.4% and 16.5%; whereas those of RUTF-receivers were 3.0% (P = 0.006) and 2.8% (P = 0.001), respectively. RUTF-receivers were less likely to have underweight (Adjusted Odd Ratio (AOR) =0.19, CI: 0.04, 0.78), and wasting (AOR = 0.24, CI: 0.07, 0.81), compared to non RUTF-receivers. Among RUTF receivers, children treated for at least four months (n = 84) were less likely to have underweight (P = 0.049), wasting (P = 0.049) and stunting (P < 0.001). Conclusions: Among HIV-positive children under ART, the provision of RUTF for at least four months was associated with low proportions of undernutrition status. RUTF has a potential to improve undernutrition among HIV-positive children under ART in the clinical settings in Dar es Salaam, Tanzania. Ndekha MJ. “Home-based therapy with ready-to-use therapeutic food is of benefit to malnourished, HIV-infected Malawian children.” Acta Paed (2005); 93: 1-4. Objective: To determine if home-based nutritional therapy will benefit a significant fraction of malnourished, HIV-infected Malawian children, and to determine if ready-to-use therapeutic food (RUTF) is more effective in home-based nutritional therapy than traditional foods. Methods: 93 HIV-positive children >1 y old discharged from the nutrition unit in Blantyre, Malawi were systematically allocated to one of three dietary regimens: RUTF, RUTF supplement or blended maize/soy flour. RUTF and maize/soy flour provided 730 kJ x kg(-1) x d(-1), while the RUTF supplement provided a fixed amount of energy, 2100 kJ/d. These children did not receive antiretroviral chemotherapy. Children were followed fortnightly. Children completed the study when they reached 100% weight-for-height, relapsed or died. Outcomes were compared using regression modeling to account for differences in the severity of malnutrition between the dietary groups. 23 Results: 52/93 (56%) of all children reached 100% weight-for-height. Regression modeling found that the children receiving RUTF gained weight more rapidly and were more likely to reach 100% weight-for-height than the other two dietary groups (p < 0.05). Conclusion: More than half of malnourished, HIV-infected children not receiving antiretroviral chemotherapy benefit from home-based nutritional rehabilitation. Home-based therapy RUTF is associated with more rapid weight gain and a higher likelihood of reaching 100% weight-forheight. Bahwere P et al. “Uptake of HIV testing and outcomes within a Community-based Therapeutic Care (CTC) programme to treat Severe Acute Malnutrition in Malawi: a descriptive study.” BMC Infect Dis. (2008); 8: 106. Background: In Malawi and other high HIV prevalence countries, studies suggest that more than 30% of all severely malnourished children admitted to inpatient nutrition rehabilitation units are HIV-infected. However, clinical algorithms designed to diagnose paediatric HIV are neither sensitive nor specific in severely malnourished children. Objectives: The present study was conducted to assess : i) whether HIV testing can be integrated into Community-based Therapeutic Care (CTC); ii) to determine if CTC can improve the identification of HIV infected children; and iii) to assess the impact of CTC programmes on the rehabilitation of HIV-infected children with Severe Acute Malnutrition (SAM). Methods: This community-based cohort study was conducted in Dowa District, Central Malawi, a rural area 50 km from the capital, Lilongwe. Caregivers and children admitted in the Dowa CTC programme were prospectively (Prospective Cohort = PC) and retrospectively (Retrospective Cohort = RC) admitted into the study and offered HIV testing and counseling. Basic medical care and community nutrition rehabilitation was provided for children with SAM. The outcomes of interest were uptake of HIV testing, and recovery, relapse, and growth rates of HIV-positive and uninfected children in the CTC programme. Student's t-test and analysis of variance were used to compare means and Kruskall Wallis tests were used to compare medians. Dichotomous variables were compared using Chi2 analyses and Fisher's exact test. Stepwise logistic regression with backward elimination was used to identify predictors of HIV infection (alpha = 0.05). Results: 1273 and 735 children were enrolled in the RC and PC. For the RC, the average age (SD) at CTC admission was 30.0 (17.2) months. For the PC, the average age at admission was 26.5 (13.7) months. Overall uptake of HIV testing was 60.7% for parents and 94% for children. HIV prevalence in severely malnourished children was 3%, much lower than anticipated. 59% of HIVpositive and 83% of HIV-negative children achieved discharge Weight-For-Height (WFH) > or = 80% of the NCHS reference median (p = 0.003). Clinical algorithms for diagnosing HIV in SAM children had poor sensitivity and specificity. Conclusion: CTC is a potentially valuable entry point for providing HIV testing and care in the community to HIV infected children with SAM. HIV-positive adults Ndekha MJ et al. “Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded, controlled trial.” BMJ. (2009); 338: b1867. Objective: To investigate the effect of two different food supplements on body mass index (BMI) in wasted Malawian adults with HIV who were starting antiretroviral therapy. Results: The mean BMI at enrolment was 16.5. After 14 weeks, patients receiving fortified spread had a greater increase in BMI and fat-free body mass than those receiving corn-soy blend: 2.2 (SD 1.9) v 1.7 (SD 1.6) (difference 0.5, 95% confidence interval 0.2 to 0.8), and 2.9 (SD 24 3.2) v 2.2 (SD 3.0) kg (difference 0.7 kg, 0.2 to 1.2 kg), respectively. The mortality rate was 27% for those receiving fortified spread and 26% for those receiving corn-soy blend. No significant differences in the CD4 count, HIV viral load, assessment of quality of life, or adherence to antiretroviral therapy were noted between the two groups. Conclusion: Supplementary feeding with fortified spread resulted in a greater increase in BMI and lean body mass than feeding with corn-soy blend. Ahoua L et al. “Nutrition outcomes of HIV-infected malnourished adults treated with ready-touse therapeutic food in sub-Saharan Africa: a longitudinal study.” J Int AIDS Soc. (2011); 14:2. Background: Among people living with HIV/AIDS, nutritional support is increasingly recognized as a critical part of the essential package of care, especially for patients in sub-Saharan Africa. The objectives of the study were to evaluate the outcomes of HIV-positive malnourished adults treated with ready-to-use therapeutic food and to identify factors associated with nutrition programme failure. Methods: We present results from a retrospective cohort analysis of patients aged 15 years or older with a body mass index of less than 17 kg/m 2 enrolled in three HIV/AIDS care programmes in Africa between March 2006 and August 2008. Factors associated with nutrition programme failure (patients discharged uncured after six or more months of nutritional care, defaulting from nutritional care, remaining in nutritional care for six or more months, or dead) were investigated using multiple logistic regression. Results: Overall, 1340 of 8685 (15.4%) HIV-positive adults were enrolled in the nutrition programme. At admission, median body mass index was 15.8 kg/m 2 (IQR 14.9-16.4) and 12% received combination antiretroviral therapy (ART). After a median of four months of follow up (IQR 2.2-6.1), 524 of 1106 (47.4%) patients were considered cured. An overall total of 531 of 1106 (48.0%) patients failed nutrition therapy, 132 (11.9%) of whom died and 250 (22.6%) defaulted from care. Men (OR = 1.5, 95% CI 1.2-2.0), patients with severe malnutrition at nutrition programme enrolment (OR = 2.2, 95% CI 1.7-2.8), and those never started on ART (OR = 4.5, 95% CI 2.7-7.7 for those eligible; OR = 1.6, 95% CI 1.0-2.5 for those ineligible for ART at enrolment) were at increased risk of nutrition programme failure. Diagnosed tuberculosis at nutrition programme admission or during follow up, and presence of diarrhoeal disease or extensive candidiasis at admission, were unrelated to nutrition programme failure. Conclusions: Concomitant administration of ART and ready-to-use therapeutic food increases the chances of nutritional recovery in these high-risk patients. While adequate nutrition is necessary to treat malnourished HIV patients, development of improved strategies for the management of severely malnourished patients with HIV/AIDS are urgently needed. Effectiveness of Plumpy’Nut and Plumpy'Doz in the prevention of Acute Malnutrition in children Isanaka S et al. « Reducing Wasting in Young Children with Preventive Supplementation: A Cohort Study in Niger.” Pediatrics. (2010); 126: e442-50 Objectives: To compare the incidence of wasting, stunting, and mortality among children aged 6 to 36 months who are receiving preventive supplementation with either ready-to-use supplementary foods (RUSFs) or ready-to-use therapeutic foods (RUTFs). Methods: Children aged 6 to 36 months in 12 villages of Maradi, Niger, (n _ 1645) received a monthly distribution of RUSFs (247 kcal [3 spoons] per day) for 6 months or RUTFs (500-kcal sachet per day) for 4 months. We compared the incidence of wasting, stunting, and mortality among children who received preventive supplementation with RUSFs versus RUTFs. 25 Results: The effectiveness of RUSF supplementation depended on receipt of a previous preventive intervention. In villages in which a preventive supplementation program was previously implemented, the RUSF strategy was associated with a 46% (95% confidence interval [CI]: 6%–69%) and 59% (95% CI: 17%–80%) reduction in wasting and severe wasting, respectively. In contrast, in villages in which the previous intervention was not implemented, we found no difference in the incidence of wasting or severe wasting according to type of supplementation. Compared with the RUTF strategy, the RUSF strategy was associated with a 19% (95% CI: 0%– 34%) reduction in stunting overall. Conclusions: We found that the relative performance of a 6-month RUSF supplementation strategy versus a 4-month RUTF strategy varied with receipt of a previous nutritional intervention. Contextual factors will continue to be important in determining the dose and duration of supplementation that will be most effective, acceptable, and sustainable for a given setting. Treatment of Moderate Acute Malnutrition in children Matilsky DK et al. “Supplementary feeding with fortified spreads results in higher recovery rates than with corn/soy blend in moderately wasted children.” J Nutr. (2009); 139: 773–778. Moderate childhood wasting is defined as having a weight-for-height Z-score (WHZ) < −2, but ≥ −3. These children are typically given fortified corn/soy blended flour (CSB), but this intervention has shown limited effectiveness. Fortified spreads (FS) can be used as supplementary foods instead; they are energy-dense, lipid-based pastes with added powdered micronutrients. In this randomized clinical effectiveness trial, the recovery rates were compared among children with moderate wasting who received either milk/peanut FS, soy/peanut FS, or CSB. Children received isoenergetic quantities of food, 314 kJ·kg −1·d−1, for up to 8 wk with biweekly follow-up. The primary outcome was recovery, defined as having a WHZ > −2. Time-event analysis was used to compare the recovery rate. A total of 1362 children were enrolled in the study. Children receiving soy/peanut FS had a similar recovery rate to those receiving milk/peanut FS and children in either FS group were more likely to recover than those receiving CSB (80% in both FS groups vs. 72% in the CSB group; P < 0.01). The rate of weight gain in the first 2 wk was greater among children receiving milk/peanut FS (2.6 g·kg −1·d−1, n = 465) or children receiving soy/peanut FS (2.4 g·kg−1·d−1, n = 450) than among children receiving CSB (2.0 g·kg −1·d−1, n = 447; P < 0.05). Rates of length gain did not differ among the 3 groups. A total of 8% of children in each feeding group developed edema, indicative of severe malnutrition, while receiving supplemental feeding. We conclude that FS are superior supplementary foods to CSB for moderately wasted Malawian children. Nackers F et al. “Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blendbased pre-mix for the treatment of childhood moderate acute malnutrition in Niger.” J Trop Pediatr. (2010); 56: 407-13. Standard nutritional treatment of moderate acute malnutrition (MAM) relies on fortified blended flours though their importance to treat this condition is a matter of discussion. With the newly introduced World Health Organization growth standards, more children at an early stage of malnutrition will be treated following the dietary protocols as for severe acute malnutrition, including ready-to-use therapeutic food (RUTF). We compared the effectiveness of RUTF and a corn/soy-blend (CSB)-based pre-mix for the treatment of MAM in the supplementary feeding programmes (SFPs) supported by Médecins Sans Frontières, located in the Zinder region (south of Niger). Children measuring 65 to <110 cm, newly admitted with MAM [weight-for-height (WHM%) between 70% and <80% of the NCHS median] were randomly allocated to receive 26 either RUTF (Plumpy’Nut, 1000 kcal day −1) or a CSB pre-mix (1231 kcal day −1). Other interventions were similar in both groups (e.g. weekly family ration and ration at discharge). Children were followed weekly up to recovery (WHM% ≥ 85% for 2 consecutive weeks). In total, 215 children were recruited in the RUTF group and 236 children in the CSB pre-mix group with an overall recovery rate of 79.1 and 64.4%, respectively (p < 0.001). There was no evidence for a difference between death, defaulter and non-responder rates. More transfers to the inpatient Therapeutic Feeding Centre (I-TFC) were observed in the CSB pre-mix group (19.1%) compared to the RUTF group (9.3%) (p = 0.003). The average weight gain up to discharge was 1.08 g kg −1 day−1 higher in the RUTF group [95% confidence interval: 0.46–1.70] and the length of stay was 2 weeks shorter in the RUTF group (p < 0.001). For the treatment of childhood MAM in Niger, RUTF resulted in a higher weight gain, a higher recovery rate, a shorter length of stay and a lower transfer rate to the I-TFC compared to a CSB pre-mix. This might have important implications on the efficacy and the quality of SFPs. 6.2 Where Plumpy’Nut has been distributed Briend A and Collins S. “Therapeutic Nutrition for Children with Severe Acute Malnutrition: Summary of African Experience.” Indian Pediatr. (2010); 47: 655-659 Across Africa, Severe Acute Malnutrition (SAM) affects approximately 3% of children under five at any time and is associated with several hundred thousand child deaths each year. Since the 1950s, efforts to treat these children as inpatients in hospitals or clinics have failed to lower mortality rates and have achieved very poor coverage. During the past 10 years new communitybased management approaches treating over 85% of SAM cases solely as outpatients using nutrient dense, lipid-based Ready to Use Therapeutic Foods have dramatically reduced mortality and increased coverage rates. In 2005, this new model was endorsed by the UN under the name Community-based Management of Acute Malnutrition (CMAM) and has now been adopted by over 25 National governments and all major relief agencies. By 2009, approximately 1 million cases of SAM were being treated annually, with programs expanding by approximately 30% year on year. Community based approaches to managing severe malnutrition. ENN Report on the Proceeding of an Inter-Agency workshop, Dublin, 8th-10th October 2003. Available at: http://www.fantaproject.org/ctc/CTCreportlow.pdf Khara T and Collins S. “Community-Therapeutic Care (CTC).” ENN Special Supplement Series, No. 2, November 2004. Available at: http://www.fantaproject.org/downloads/pdfs/ENNctc04.pdf Collins S. “Community-based therapeutic care - A new paradigm for selective feeding in nutritional crises.” Humanitarian Practice Network. Network paper No 28. November 2004. Available online. 6.3 Related references ACC/SCN “Working group on nutrition in emergencies.” Field Exchange (August 2001); Issue: 13:13. Achour L et al. “Comparison of gastric emptying of a solid and a liquid nutritional rehabilitation food.” Eur J Clin Nutr (2001); 55: 769-772. 27 Alam NH et al. “Efficacy and safety of a modified oral rehydration solution (resoMaL) in the treatment of severely malnourished children with watery diarrhea.” J. Pediatr. (2003); 143: 614– 619. Amadi B et al. “Reduced production of sulphated glycosaminoglycans occurs in Zambian children with kwashiorkor but not marasmus.” Am. J. Clin.Nutr. (2009); 89: 592–600. 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Available at: http://www.who.int/nutrition/publications/moderate_malnutrition/FNBv30n3_suppl_paper1.pd f Greco L et al. “Effect of a low-cost food on the recovery and death rate of malnourished children.” J Pediatr Gastroenterol Nutr. (2006); 43:512-7. 28 Heikens GT et al. “Long-stay versus short-stay hospital treatment of children suffering from severe protein-energy malnutrition.” Eur. J. Clin Nutr. (1994); 48: 873–882. Hossain MI et al. “Impact of community-based follow-up care, with or without food supplementation and/or psychosocial stimulation, on the recovery of severely underweight Bangladeshi children: a randomized intervention trial.” Mal Med J. (2009); 21:140. Human Vitamin and Mineral Requirements: Report of a joint FAO/WHO expert consultation, Bangkok, Thailand. Rome: Food and Agriculture Organisation. (2002) Karaolis N et al. WHO guidelines for severe malnutrition: are they feasible in rural African hospitals? Arch Dis Child (2007); 92:198–204. Kauffman CA et al. “Fever and malnutrition: endogenous pyrogen/ interleukin-1 in malnourished patients.” Am J Clin Nutr. (1986); 44: 449–452. Khanum S et al. “Controlled trial of three approaches to the treatment of severe malnutrition.” Lancet (1994); 344: 1728–1732. Khara T and Collins S. “Community-Therapeutic Care (CTC).” ENN Special Supplement ( November 2004); Series, No. 2. Lopriore C et al. “Spread fortified with vitamins and minerals induces catch-up growth and eradicates severe anaemia in stunted refugee children aged 3–6 y.” Am J Clin Nutr. (2004); 80: 973–981. Maleta K et al. “Supplementary feeding of underweight, stunted Malawian children with a ready-to-use food”. J Pediatr Gastroenterol Nutr. (2004); 38: 152–158. Manary MJ and Brewster DR. “Potassium supplementation in kwashiorkor.” J Pediatr Gastroenterol Nutr (1997); 24: 194–201. Myatt M and Duffield A. “Weight-for-height and MUAC for estimating the prevalence of acute undernutrition?” [online] http://www.humanitarianreform.org/humanitarianreform/ Portals/1/cluster%20approach%20page/clusters %20pages/Nutrition/Myatt_sAve_UK_MUAC_Nutrition_Cluster_Oct22_07_section1_2_Optimize d.pdf (2007) Navarro-Colorado C et al. “Comparison of a liquid with a dry ready to use Therapeutic food for the rehabilitation of severely malnourished adults during famines: a randomised clinical trial.” Unpublished manuscript. Navarro-Colorado Cand Laquière S. “Use of Solid Ready-to-Use-Therapeutic-Food (BP100) Vs F100 milk for Rehabilitation of Severe Malnutrition during emergencies: A Clinical Trial in Sierra Leone.” ENN Field Exchange.(March 2005); Issue 24. Nestel P et al. “Complementary Food Supplements to achieve Micronutrient Adequacy for infants and young children” J Pediatr Gastroenterol Nutr. (2003); 36:316-28. Pelletier DL et al. “The effects of malnutrition on child mortality in developing countries.“ Bull.World Health Organ. (1995); 73: 443–448. Prudhon C et al. “Proceedings of the WHO, UNiCeF, and SCN informal consultation on community-based management of severe malnutrition in children.” Food Nutr. Bull. (2006); 27:99–s104. Sadler K. “Key issues in the success of community-based management of severe malnutrition” Food Nutr Bull (2006); 27: S49-S82. Schoonees A et al. “Ready-to-use therapeutic food for home-based treatment of severe acute malnutrition in children from six months to five years of age.” Cochrane Database Syst Rev . (2013) Schroeder DG and Brown KH. “Nutritional status as a predictor of child survival: summarizing the association and quantifying its global impact.” Bull. World Health Organ.(1994); 72:569–579. UNICEF. State of the World’s Children 2009: Maternal and Newborn Health. (2009) 29 WHO & UNICEF. WHO child growth standards and the identification of severe acute malnutrition in infants and children. Available at: http://www.who.int/nutrition/publications/severemalnutrition/9789241598163_eng.pdf WHO. “Management of severe malnutrition: a manual for physicians and other senior health workers.” (1999) WHO. “Management of the Child with a Serious Infection or Severe Malnutrition. Guidelines for Care at the First-referral Level in Developing Countries.” (2000) WHO. Updates on the management of severe acute malnutrition in infants and children. (2013) Available at: http://www.who.int/nutrition/publications/guidelines/updates_management_SAM_infantandch ildren/en/index.html WFP. “Improving corn-soy blend and other fortified blended foods, why and how.” (2008) 30 7 PRODUCTION 7.1 Global Production Plumpy'Nut consolidated production 30 000 T 26 577 T 26 511 T 23 542 T 25 000 T 24 730 T 20 101 T 20 000 T 15 467 T 15 000 T Edesia 13 654 T PlumpyField 10 000 T Nutriset 5 000 T 0T 2008 7.2 2009 2010 2011 2012 2013 End of Nov 14 Local Production From its creation, Nutriset has supported local production. In 2005, a local and global network of producers bad been created: PlumpyField. Based on each producer’s competencies and their national specificities, the network unites 11 entrepreneurs (NGO, private companies, non-for-profits) who are manufacturing Plumpy’Nut in countries with a high level of under-nutrition. These organizations, by purchasing raw materials locally, also have a positive impact on agricultural and economic development. 31 Plumpy’Nut is available from the following PlumpyField partners: 32 Name Tel / Fax number Contact name Tel: +227 20 74 37 10 STA (Société +227 90 44 43 42 de Transformation Fax: +227 20 74 37 11 Alimentaire) Mr. Ismael Barmou General Manager E-mail direction@sta.ne +251 116 519 909 Mr Belete Beyene, Hilina Enriched Tel: Mobile: +251 911 238 453 Director Foods P.L.C. belete6@hotmail.com Ms Hilina Belete, Deputy General Manager Operations hbelete@hilinafoods.com EDESIA Mrs Navyn Salem, Executive Director Mrs Maria Kasparian, Director of Operations nsalem@edesiaglobal.o rg Mr. Thierry Barday General Manager thierry.bardai@basan. mg Fax: +251 114 421 252 Tel: +1.401.272.5521 Fax: +1.401.272.5526 mkasparian@edesiaglo bal.org JB / TANJAKA FOOD Tel: +261 20 22 223 73 Mob: +261 32 07 477 61 Fax: +261 20 22 280 64 NUTRIVITA FOODS PVT. LTD. Tel.: +91 9545 5033 71 Mr. Nilkamal Joshi, Mobile: +91 9545 0261 61 General Manager info@nutrivita.in nilkamalj@nutrivita.in Tel: +91 22 2687 3855 Mr. Akhil Jain Mobile: +91 9920 3022 39 Production akhilj@nutrivita.in Manager factory@nutrivita.in Meds and Food Haiti: +509 2813 9004 for Kids (MFK) USA : +1 314 420 1634 SAMIL Tel. : +249 9123 03866 Fax: +249 83 563515 INNOFASO Tel: +226 68 24 20 10 Tel: +226 78 80 62 09 Mrs Patricia Wolff Executive Director Mr. Hisham Salih Abdelrahman Yagoub General Manager Ms. Virginie Claeyssens General Manager Mr. Omar Coulibaly Project coordinator 33 pwolff@mfkhaiti.org hisham@yagoubgroup.c om virginie.claeyssens@inn ofaso.com omar.coulibaly@innofaso .com 8 FAQs Why did we call it Plumpy’Nut? When Plumpy’Nut was launched, Nutriset wanted to create a turning point in the care of malnutrition with this ready-to-use product. To support this innovation, we wanted to create also a change in the name and use meaningful words instead of number used before and only understandable by few. The product being initially designed for children, we were thus looking for a word from the childish universe. The word “Plumpy” has been chosen in relation to the shape Nutriset wanted to give to the children that would eat the product. “Nut” was naturally added to give some information about the product’s content. Even if the name was surprising at that moment, it is now adopted by all, from humanitarian actors to final users. Does Plumpy’Nut increase the child’s need for water? Plumpy’Nut is not likely to increase the child’s need for water, but it is recommended to make drinkable water available for the child while consuming Plumpy’Nut. What about risks associated with peanut allergies? Although limited epidemiological data exists on peanut allergies in developing countries, peanut allergies seem to be rare in settings where peanut-based nutrition products are distributed. Over the last ten years several million children have received peanut-based nutrition products and no severe allergic reactions have been reported 17,18,19,20,21. What are the impacts of the patent on the eco-system of Plumpy’Nut? Since 2005, PlumpyField members supply Plumpy’Nut to their countries and others nearby using the highest industry quality standards. The patent protects livelihoods by preventing local markets from being flooded with sometimes fake competing products manufactured in 17Gupta RS et al. “The prevalence, severity, and distribution of childhood food allergy in the United States.” Pediatrics. (2011);128:9-17. 18Yang Z. “Are peanut allergies a concern for using peanut-based formulated foods in developing countries? “Food Nutr Bull. (2010); 31:S147-53. 19Thompson RL et al. “Peanut sensitisation and allergy: influence of early life exposure to peanuts.” Br J Nutr. (2010);103:1278-86. 20Greer FE et al. “Effects of early nutritional interventions on the development of atopic disease in infants and children: the role of maternal dietary restriction, breastfeeding, timing of introduction of complementary foods, and hydrolyzed formulas.” Pediatrics. (2008); 121:183-91. 21Burks AW et al. “NIAID-sponsored 2010 guidelines for managing food allergy: applications in the pediatric population.” Pediatrics. (2011); 128:955-65. 34 more developed countries. It also allows nascent companies sufficient time to become more efficient and competitive with global suppliers. The price of Plumpy’Nut and similar products (widely called RUTFs) has not been augmented by the patent, it was demonstrated that prices from patented suppliers and not patented supplier are the same. Patented suppliers can even be cheaper. The product’s greatest cost comes from the commodities needed to make it. The patent does not cause a global shortage of Plumpy’Nut. There are still millions of severely malnourished children around the world who are not being reached by Plumpy’Nut and this is mainly due to a limited number of programmes and associated funding to identify and treat these children at a country level. In countries such as Ethiopia, where no Plumpy’Nut patent has been registered but where the prevalence and incidence of SAM in children under 5 is amongst the highest in the world, the majority of RUTF used by communities has been and still is Plumpy’Nut. Can Plumpy’Nut be used in case of HIV-AID patient? WHO recommends the use of among malnourished children suffering from HIV/AIDS 22. Several studies both on ARV-naïve and ARV-treated children have demonstrated the safety and efficacy of Plumpy’Nut to overcome malnutrition23,24,25,26. Concerning the nutritional support of adults with HIV-AIDS , Nutriset has created Plumpy’Soy, which is more adapted to adult needs in terms of micronutrients. Can Plumpy’Nut be used for ill patients in more developed countries? Products developed by Nutriset aim to treat and/or prevent specific nutritional deficiencies by for instance compensating for monotonous diets or inappropriate feeding of infants and young children. Acceptability and efficacy of our products are systematically evaluated through rigorous scientific studies. At present, no study using our products aimed at treating or preventing acute malnutrition has been run in an occidental context. 22WHO. “Guidelines for an integrated approach to the nutritional care of HIV-infected children (6 months – 14 years).” 2009 23Ndekha MJ et al. “Home-based therapy with ready-to-use therapeutic food is of benefit to malnourished, HIV-infected Malawian children.” Acta Paediatr. (2005);94:222-5. 24Fergusson P et al. “Nutritional recovery in HIV-infected and HIV-uninfected children with severe acute malnutrition.” Arch Dis Child (2009); 94:512–516. 25Sunguya BF et al. “Ready to Use Therapeutic Foods (RUTF) improves undernutrition among ART-treated, HIV-positive children in Dar es Salaam, Tanzania.” Nutr J. (2012); 11:60. 26Kim MH et al. “Prompt initiation of ART With therapeutic food is associated with improved outcomes in HIV-infected Malawian children with malnutrition.” J Acquir Immune Defic Syndr. (2012); 59:173-6. 35 ACRONYMS AND ABREVIATIONS ART Anti-Retroviral Therapy BMI Body Mass Index CMAM Community-Based Management of Acute CSB Corn Soy blend CTC Community-Based Therapeutic Care FANTA Food and Nutrition Technical Assistance FAO Food and Agriculture Organization F75 Therapeutic Milk, 75 kcal/100ml F100 Therapeutic Milk, 100 kcal/100ml GMO Genetically Modified Organism HIV/AIDS Human Immunodeficiency Virus/Acquired MAM Moderate Acute Malnutrition NCHS National Centre for Health Statistics RUSF Ready to Use Supplementary Food RUTF Ready to Use Therapeutic Food SAM Severe Acute Malnutrition SFP Supplementary Feeding Program TFC Therapeutic Feeding Centre UNU United Nation University WFH Weight-For-Height WHZ Weight-For-Height z score WHO World Health Organization 36