|
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. completion2026-06
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
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhaseN/A
SponsorWashington University School of Medicine
Started2023-12-05
Est. completion2026-06
Eligibility
Age6 Months – 59 Months
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06154174