Comparison of an Alternative Therapeutic Food for the International Food Aid Market to a Standard Ready-to-use Therapeutic Food (RUTF) for the Treatment of Severe Acute Malnutrition in Children
1 other identifier
interventional
1,568
1 country
1
Brief Summary
In this clinical non-inferiority trial, two foods will be compared for the treatment of SAM, testing the hypothesis that the difference in recovery rates and growth between the two test groups will be no greater than 5 percent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedStudy Start
First participant enrolled
October 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2019
CompletedJanuary 13, 2020
January 1, 2020
11 months
January 16, 2018
January 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mid-upper-arm circumference
MUAC ≥ 12.5
2 to 12 weeks
Weight-for-height z score
WHZ≥-2
2 to 12 weeks
Secondary Outcomes (1)
Adverse symptoms
2 to 12 weeks
Study Arms (2)
Alternative
EXPERIMENTALParticipants will receive approximately 190 kcal/kg/day of alternative RUTF till recovery or up to 12 weeks of treatment.
Standard
ACTIVE COMPARATORParticipants will receive approximately 190 kcal/kg/day of standard RUTF till recovery or up to 12 weeks of treatment.
Interventions
The alternative RUTF contains oat, peanuts, sugar, milk powder, vegetable oil as well as premix containing concentrated minerals and vitamins and emulsifier.
Standard RUTF contains peanut paste, sugar, non-fat dried milk (NFDM), vegetable oil, a premix containing concentrated minerals and vitamins, and emulsifier.
Eligibility Criteria
You may qualify if:
- WHZ \< -3
- MUAC \<11.5cm
- bipedal edema
You may not qualify if:
- children currently involved in another research trial or feeding program
- developmentally delayed
- chronic debilitating illness (such as cerebral palsy)
- history of peanut or milk allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Project Peanut Butter
Freetown, Sierra Leone
Related Publications (1)
Hendrixson DT, Godbout C, Los A, Callaghan-Gillespie M, Mui M, Wegner D, Bryant T, Koroma A, Manary MJ. Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: a triple-blind, randomised controlled clinical trial. Gut. 2020 Dec;69(12):2143-2149. doi: 10.1136/gutjnl-2020-320769. Epub 2020 Mar 16.
PMID: 32179568DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2018
First Posted
January 23, 2018
Study Start
October 16, 2018
Primary Completion
September 2, 2019
Study Completion
September 2, 2019
Last Updated
January 13, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share