Actively Recruiting
Choline to Improve Malnutrition and Enhance Cognition
Led by Washington University School of Medicine · Updated on 2026-03-17
1500
Participants Needed
10
Research Sites
151 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
P
Project Peanut Butter
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Choline to Improve Malnutrition and Enhance Cognition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 59 months
- Mid-upper arm circumference less than 11.5 cm and/or weight-for-length z-score below -3 and/or presence of bilateral pedal pitting edema
- Willingness to follow all study procedures and availability for the entire study duration, including no plans to move from the local clinic area
You will not qualify if you...
- Complicated severe acute malnutrition requiring immediate hospitalization or inability to tolerate a 30g test dose of RUTF
- Participation in another feeding program within the past month
- Known allergy to peanut, milk, or fish ingredients in study food
- Intention to move away from the study area within 9 months
- Developmental delay
- Presence of a chronic severe medical condition other than tuberculosis or HIV, such as congenital heart disease
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Makhwira
Makhwira, Chikwawa, Malawi
Actively Recruiting
2
Mitondo
Mitondo, Chikwawa, Malawi
Actively Recruiting
3
Nkhate
Nkhate, Chikwawa, Malawi
Actively Recruiting
4
Chipolonga
Chipolonga, Machinga, Malawi
Actively Recruiting
5
Chikonde
Chikonde, Mulanje, Malawi
Actively Recruiting
6
Mbiza
Mbiza, Mulanje, Malawi
Actively Recruiting
7
Milonde
Milonde, Mulanje, Malawi
Actively Recruiting
8
Muloza
Muloza, Mulanje, Malawi
Actively Recruiting
9
Namasalima
Namasalima, Mulanje, Malawi
Actively Recruiting
10
Naphimba
Naphimba, Mulanje, Malawi
Actively Recruiting
Research Team
M
Mark J Manary, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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