← Back to all trials
Active Not Recruiting
NCT06154174
Choline to Improve Malnutrition and Enhance Cognition
Conditions: Severe Acute Malnutrition, Cognitive Impairment, Wasting, Kwashiorkor
Sex: All
Ages: 6 Months – 59 Months
Healthy volunteers: No
Phase: NA
Enrollment: 1500
Sponsor: Washington University School of Medicine
Location: Makhwira Makhwira Chikwawa
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
Source: ClinicalTrials.gov (NCT06154174). StuddyBuddy aggregates publicly available trial information.