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Choline to Improve Malnutrition and Enhance Cognition
RECRUITINGN/ASponsored by Washington University School of Medicine
Actively Recruiting
PhaseN/A
SponsorWashington University School of Medicine
Started2023-12-05
Est. completion2026-11
Eligibility
Age6 Months – 59 Months
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06154174
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
Age: 6 Months – 59 MonthsHealthy volunteers accepted
Inclusion Criteria: * 6-59 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 Criteria: * 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
Conditions5
Cognitive ImpairmentKwashiorkorSevere Acute MalnutritionWastingWeight Loss
Interventions1
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Actively Recruiting
PhaseN/A
SponsorWashington University School of Medicine
Started2023-12-05
Est. completion2026-11
Eligibility
Age6 Months – 59 Months
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06154174