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Researchers are evaluating whether adding a daily 500mg dose of 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 and is linked to increased risks of infection, hospitalization, death, stunted growth, and impaired cognitive development. This trial builds on previous findings suggesting that modifying RUTF composition can support better brain development after SAM. The study compares two groups of children receiving either standard RUTF or RUTF supplemented with choline (C-RUTF). Both foods are peanut paste-based and meet Codex Alimentarius standards. Participants will receive two sachets daily and return to clinics every two weeks for assessments and to collect more RUTF, continuing treatment for up to 12 weeks or until clinical recovery. After treatment, children will be tested using the Malawi Developmental Assessment Tool (MDAT), with a follow-up MDAT test 5 to 7 months later to measure cognitive outcomes. Children's progress will be closely monitored through routine clinic visits where researchers will measure growth, ask illness-related questions, and collect blood spots. The primary outcome is the global z-score from the MDAT at 6 months after treatment for SAM. The study aims to understand if choline addition can enhance cognitive recovery in malnourished children, with careful safety and developmental monitoring throughout the trial period.

Age: 6Months - 59MonthsAll GendersPhase Not Applicable
10 locations
Chikuwita Clinical Trials | DecenTrialz