Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?
NCT ID: NCT04216043
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1102 participants
INTERVENTIONAL
2020-09-16
2022-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RUSF skimmed milk powder
RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF skimmed milk powder
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF milk protein concentrate and sucrose
RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF milk protein concentrate and sucrose
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF soy protein and whey permeate
RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF soy protein and whey permeate
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF soy and sucrose
RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF soy and sucrose
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Interventions
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RUSF skimmed milk powder
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF milk protein concentrate and sucrose
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF soy protein and whey permeate
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
RUSF soy and sucrose
ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* in another supplemental feeding program
* debilitating illness
* history of peanut or milk allergy
6 Months
59 Months
ALL
No
Sponsors
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Project Peanut Butter, Sierra Leone
UNKNOWN
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Mark Manary, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Project Peanut Butter Factory
Freetown, , Sierra Leone
Countries
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References
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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.
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.
Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906.
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.
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.
Son M, Laury ML, Stephenson KB, May T, Hendrixson DT, Koroma AS, Ngegbai AS, Song JH, Naskidashvili N, Goo YA, Manary MJ. The Impact of Milk on Gut Permeability, Fecal 16S rRNA Gene Microbiota Profiling, and Fecal Metabolomics in Children with Moderate Malnutrition in Sierra Leone: A Double-Blind, Randomized Controlled Trial. Am J Clin Nutr. 2024 Nov;120(5):1114-1124. doi: 10.1016/j.ajcnut.2024.09.018. Epub 2024 Sep 21.
Other Identifiers
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201912091
Identifier Type: -
Identifier Source: org_study_id
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