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This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM.
Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary feeding program.
Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will differ by no more than three percent.
This will be a randomized, double-blinded, controlled clinical effectiveness trial assessing the treatment of moderate acute malnutrition (MAM) with one of two supplementary foods for a period of up to 12 weeks. The overall purpose of this research is to see if your child will grow and gain weight more rapidly using one of two peanut butter foods as he/she recovers from protein-energy malnutrition.
Subjects will be given a soy or dairy peanut butter food at their home. The peanut butter food has either small amounts of soya protein and minerals (iron, zinc) or whey powder and minerals added to them. Subjects will have enough food to feed the child for 2 weeks, and asked to return every 2 weeks to be weighed, measured and given more food. The parents of the subjects will be asked to feed their child this food until his/her weight has returned to what is considered normal for the child's height. Subjects will then return after 3, 6 and 12 months for a check-up. At these check-ups, he/she will be measured and examined.
The current standard of care is to allow the child to recover without food or with supplemental flour thus all participation is related to research. Participation in this study is expected to last 8-12 weeks of therapy with follow up in 12 months after completion of the therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey permeate RUSF | Experimental | 75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. |
|
| Soy Protein RUSF | Active Comparator | 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey permeate RUSF | Dietary Supplement | Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Whey RUSF contains whey permeate, WPC 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery From Moderate Acute Malnutrition (MAM) | The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Amount of weight gained over the course of treatment | 3 months |
| Height | Amount of height gained over the intervention period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Manary, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Peanut Butter | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18207566 | Background | Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available. | |
| 15213048 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Whey Permeate RUSF | 75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Whey RUSF contains whey permeate, WPC 80 (contains |
| FG001 | Soy Protein RUSF | 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Soy RUSF contains extruded soy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Whey Permeate RUSF | 75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Whey RUSF contains whey permeate, WPC 80 (contains |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recovery From Moderate Acute Malnutrition (MAM) | The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default). | Posted | Count of Participants | Participants | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Whey Permeate RUSF | 75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Whey RUSF contains whey permeate, WPC 80 (contains |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Manary | Washington University School of Medicine in St. Louis | 314 454 2178 | manarymj@wustl.edu |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Soy Protein RUSF | Dietary Supplement | Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. |
|
| 3 months |
| Mid-Upper-Arm Circumference (MUAC) Gain | Gain in mid-upper arm circumference | 3 months |
| Time to Graduation | The amount of time required for a patient to reach recovery | 3 months |
| Adverse Events | Any adverse events from the supplementary foods reported in the 3 month time frame. | 3 months |
| Caulfield LE, de Onis M, Blossner M, Black RE. Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr. 2004 Jul;80(1):193-8. doi: 10.1093/ajcn/80.1.193. |
| 10944483 | Background | Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906. |
| 12423980 | Background | Ezzati M, Lopez AD, Rodgers A, Vander Hoorn S, Murray CJ; Comparative Risk Assessment Collaborating Group. Selected major risk factors and global and regional burden of disease. Lancet. 2002 Nov 2;360(9343):1347-60. doi: 10.1016/S0140-6736(02)11403-6. |
| 17436220 | Background | George E, Noel F, Bois G, Cassagnol R, Estavien L, Rouzier Pde M, Verdier RI, Johnson WD, Pape JW, Fitzgerald DW, Wright PF. Antiretroviral therapy for HIV-1-infected children in Haiti. J Infect Dis. 2007 May 15;195(10):1411-8. doi: 10.1086/514823. Epub 2007 Apr 3. |
| 19225128 | Background | Matilsky DK, Maleta K, Castleman T, Manary MJ. Supplementary feeding with fortified spreads results in higher recovery rates than with a corn/soy blend in moderately wasted children. J Nutr. 2009 Apr;139(4):773-8. doi: 10.3945/jn.108.104018. Epub 2009 Feb 18. |
| 20332221 | Background | Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23. |
| 20522296 | Background | Lagrone L, Cole S, Schondelmeyer A, Maleta K, Manary MJ. Locally produced ready-to-use supplementary food is an effective treatment of moderate acute malnutrition in an operational setting. Ann Trop Paediatr. 2010;30(2):103-8. doi: 10.1179/146532810X12703901870651. |
| 22170366 | Background | LaGrone LN, Trehan I, Meuli GJ, Wang RJ, Thakwalakwa C, Maleta K, Manary MJ. A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Am J Clin Nutr. 2012 Jan;95(1):212-9. doi: 10.3945/ajcn.111.022525. Epub 2011 Dec 14. |
| 17076211 | Background | Myatt M, Khara T, Collins S. A review of methods to detect cases of severely malnourished children in the community for their admission into community-based therapeutic care programs. Food Nutr Bull. 2006 Sep;27(3 Suppl):S7-23. doi: 10.1177/15648265060273S302. |
| 19706211 | Background | Knueppel D, Demment M, Kaiser L. Validation of the Household Food Insecurity Access Scale in rural Tanzania. Public Health Nutr. 2010 Mar;13(3):360-7. doi: 10.1017/S1368980009991121. Epub 2009 Aug 26. |
| 17076214 | Background | Manary MJ. Local production and provision of ready-to-use therapeutic food (RUTF) spread for the treatment of severe childhood malnutrition. Food Nutr Bull. 2006 Sep;27(3 Suppl):S83-9. doi: 10.1177/15648265060273S305. |
| 26864368 | Result | Stobaugh HC, Ryan KN, Kennedy JA, Grise JB, Crocker AH, Thakwalakwa C, Litkowski PE, Maleta KM, Manary MJ, Trehan I. Including whey protein and whey permeate in ready-to-use supplementary food improves recovery rates in children with moderate acute malnutrition: a randomized, double-blind clinical trial. Am J Clin Nutr. 2016 Mar;103(3):926-33. doi: 10.3945/ajcn.115.124636. Epub 2016 Feb 10. |
| Other |
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| SAM at Enrollment |
|
| Measurement error |
|
| BG001 | Soy Protein RUSF | 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Soy RUSF contains extruded soy |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MUAC, cm | Median | Standard Deviation | cm |
|
| OG001 | Soy Protein RUSF | 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Soy RUSF contains extruded soy |
|
|
| Secondary | Weight | Amount of weight gained over the course of treatment | Posted | Mean | Standard Deviation | Gain (g/kg/day) | 3 months |
|
|
|
| Secondary | Height | Amount of height gained over the intervention period. | Posted | Mean | Standard Deviation | mm/d | 3 months |
|
|
|
| Secondary | Mid-Upper-Arm Circumference (MUAC) Gain | Gain in mid-upper arm circumference | Posted | Mean | Standard Deviation | mm/d | 3 months |
|
|
|
| Secondary | Time to Graduation | The amount of time required for a patient to reach recovery | Posted | Mean | Standard Deviation | days | 3 months |
|
|
|
| Secondary | Adverse Events | Any adverse events from the supplementary foods reported in the 3 month time frame. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 1,144 |
| 0 |
| 1,144 |
| EG001 | Soy Protein RUSF | 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Soy RUSF contains extruded soy f | 0 | 1,086 | 0 | 1,086 |
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