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

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.

Choline to Improve Malnutrition and Enhance Cognition