What is choline studying for severe acute malnutrition?

This clinical trial is studying whether adding a daily dose of choline to therapeutic food can improve cognitive development in children with severe acute malnutrition. Researchers want to see if choline helps brain recovery alongside standard nutritional treatment. The study is sponsored by Washington University School of Medicine and conducted in Malawi.

Who may be eligible for this severe acute malnutrition clinical trial?

Children aged 6 to 59 months diagnosed with severe acute malnutrition can be eligible. The study includes both boys and girls but excludes children with complicated malnutrition needing hospitalization or developmental delays. Recent feeding program participation and allergies to peanuts, milk, or fish may also disqualify a child. Please review eligibility criteria for more details.

Is there any cost to participate in this severe acute malnutrition clinical trial?

Study-related care, including the therapeutic food and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants should plan accordingly for transportation costs.

Actively Recruiting

Phase Not Applicable

Age: 6Months - 59Months

All Genders

ID06154174

Adding Choline to Therapeutic Food to Improve Brain Development in Malawian Children with Severe Acute Malnutrition Aged 6 to 59 Months

Led by Washington University School of Medicine · Updated on 2026-03-17

1500

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 6Months - 59Months

All Genders

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

Research Team

Mark J Manary, MD

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