Choline to Improve Malnutrition and Enhance Cognition
Washington University School of Medicine
1,500 participants
Dec 5, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi. The main question it aims to answer is: \- Will the addition of a 500mg daily dose of choline to RUTF during treatment for SAM improve cognitive development among 6-59-month-old Malawian children compared with standard RUTF without added choline?
Eligibility
Inclusion Criteria3
- months of age
- mid-upper arm circumference \< 11.5 cm and/or weight-for-length z-score \< -3 and/or presence of bilateral pedal pitting edema
- willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic
Exclusion Criteria6
- features of complicated SAM: inability to tolerate a 30g test dose of RUTF, breathing difficulties, mental status changes, sepsis, or physician/nursing clinical assessment that the child needs immediate hospitalization
- participation in a separate feeding program within the past month
- known allergy to study food ingredient (peanut, milk, fish)
- intention to move away from catchment area within 9 months
- developmental delay
- presence of a chronic severe medical condition (other than TB and HIV), such as congenital heart disease
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Interventions
Choline added to peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications
Standard peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications
Oral amoxicillin tablets twice per day for 7 days dosed based on weight
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06154174