Actively Recruiting
Choline to Improve Malnutrition and Enhance Cognition in Children with Severe Acute Malnutrition
Led by Washington University School of Medicine · Updated on 2026-03-17
1500
Participants Needed
10
Research Sites
N/A
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
Researchers are evaluating whether adding choline to ready-to-use therapeutic food (RUTF) can improve cognitive development in children aged 6 to 59 months with severe acute malnutrition (SAM) in Malawi. SAM affects millions of children worldwide, leading to increased risks of infection, hospitalization, death, stunted growth, and impaired cognitive development. Previous studies indicated that modifying the fatty acid content of RUTF improved brain development, and this study explores if adding choline, an essential nutrient for brain function, offers additional cognitive benefits. This trial compares two groups of children: one receiving RUTF with an added daily dose of 500 mg choline (C-RUTF) and the other receiving standard RUTF with only 5 mg choline for masking (S-RUTF). Both groups receive two sachets daily, providing approximately 1000 Kcal, 14g protein, 28g fat, and 14 micronutrients. Children are treated for up to 12 weeks or until recovery, with follow-up visits every two weeks to monitor health, growth, and RUTF supply. Participants undergo cognitive testing using the Malawi Developmental Assessment Tool (MDAT) at the end of treatment and again 5 to 7 months later to assess long-term development. Researchers collect blood samples and track recovery, growth rates, and health outcomes during treatment and follow-up. The study aims to measure differences in cognitive scores six months after treatment to determine if choline supplementation aids brain development in malnourished children.
CONDITIONS
Brief Title
Choline to Improve Malnutrition and Enhance Cognition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is between 6 and 59 months old
- Diagnosed with severe acute malnutrition defined by mid-upper arm circumference less than 11.5 cm and/or weight-for-length z-score less than -3 and/or bilateral pedal pitting edema
- Willingness to comply with all study procedures and availability for the study duration, including no plans to move away from the clinic area
You will not qualify if you...
- Signs of complicated severe acute malnutrition needing immediate hospitalization such as inability to tolerate test dose of therapeutic food, breathing problems, mental status changes, or sepsis
- Participation in a feeding program within the past month
- Known allergy to peanuts, milk, or fish
- Plans 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive 2 sachets per day of either choline-enriched or standard ready-to-use therapeutic food (RUTF) and return to clinic for repeat measurements and illness monitoring until recovery or up to 12 weeks.
Fortnightly visits for up to 12 weeks
Duration - 5 to 7 months after treatment
Participants return for developmental assessment and blood collection near the end of treatment, then for a final developmental assessment 5 to 7 months later to evaluate cognitive outcomes.
2 visits (in-person)
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
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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