Choline to Improve Malnutrition and Enhance Cognition

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Balchem Corporation; Kamuzu University of Health Sciences; Project Peanut Butter
• Treatments: Amoxicillin; Choline

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