Status:
COMPLETED
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
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
The Children's Investment Fund Foundation
Conditions:
Malnutrition
Eligibility:
All Genders
6-5 years
Phase:
NA
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...
Detailed Description
This will be a randomised, triple-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods until the child is recovered or for a period of up...
Eligibility Criteria
Inclusion
- Children aged 6-59 months with one or combination of the following
- WHZ \< -3
- MUAC \<11.5cm
- bipedal edema
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2019
Estimated Enrollment :
1568 Patients enrolled
Trial Details
Trial ID
NCT03407326
Start Date
October 16 2018
End Date
September 2 2019
Last Update
January 13 2020
Active Locations (1)
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1
Project Peanut Butter
Freetown, Sierra Leone