Active — Not RecruitingNot Applicable

Choline to Prevent SAM in Children With MAM

Malawi1,500 participantsStarted 2024-03-18

Plain-language summary

The goal of this clinical trial is to test choline supplementation in children with moderate acute malnutrition in Malawi. The main question it aims to answer is: Will provision of RUSF with added choline (500mg/day) throughout treatment of moderate acute malnutrition (up to 12 weeks) reduce deterioration to severe acute malnutrition among 6-59 month old Malawian children compared with standard RUSF?

Who can participate

Age range6 Months – 59 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 6-59 months of age * uncomplicated MAM (mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm and/or weight-for-length z-score (WLZ) ≥ -3 and \< -2) * availability for the duration of the study with no plan to move from the catchment area of a participating clinic Exclusion Criteria: * presence of nutritional edema * features of complicated MAM, such as mental status changes or breathing issues * participation in another feeding program * known allergy to study food ingredient * intention to move away from catchment area within 9 months * developmental delay * presence of a chronic severe medical condition (other than TB or HIV) such as congenital heart disease

What they're measuring

Percentage of pairwise comparisons with wins of Clinical Benefit, which is a composite of time-to-SAM, graduation, and rate of weight change between enrollment and 4-week follow-up.

Timeframe: 2-12 weeks of supplementary feeding

Trial details

NCT IDNCT06214897

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Moderate Acute Malnutrition trials