← Back to Clinical Trials
Recruiting NCT06154174

Choline to Improve Malnutrition and Enhance Cognition

Trial Parameters

Condition Severe Acute Malnutrition
Sponsor Washington University School of Medicine
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,500
Sex ALL
Min Age 6 Months
Max Age 59 Months
Start Date 2023-12-05
Completion 2026-11
Interventions
C-RUTF (Ready-to-Use Therapeutic Food with added choline)S-RUTF (Ready-to-Use Therapeutic Food without added choline)Amoxicillin

Brief 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 Criteria

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

Related Trials