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Choline to Improve Malnutrition and Enhance Cognition
Sponsor: Washington University School of Medicine
Summary
The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi. The main question it aims to answer is: \- Will the addition of a 500mg daily dose of choline to RUTF during treatment for SAM improve cognitive development among 6-59-month-old Malawian children compared with standard RUTF without added choline?
Key Details
Gender
All
Age Range
6 Months - 59 Months
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2023-12-05
Completion Date
2026-11
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
C-RUTF (Ready-to-Use Therapeutic Food with added choline)
Choline added to peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications
S-RUTF (Ready-to-Use Therapeutic Food without added choline)
Standard peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications
Amoxicillin
Oral amoxicillin tablets twice per day for 7 days dosed based on weight
Locations (10)
Makhwira
Makhwira, Chikwawa, Malawi
Mitondo
Mitondo, Chikwawa, Malawi
Nkhate
Nkhate, Chikwawa, Malawi
Chipolonga
Chipolonga, Machinga, Malawi
Chikonde
Chikonde, Mulanje, Malawi
Mbiza
Mbiza, Mulanje, Malawi
Milonde
Milonde, Mulanje, Malawi
Muloza
Muloza, Mulanje, Malawi
Namasalima
Namasalima, Mulanje, Malawi
Naphimba
Naphimba, Mulanje, Malawi