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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06154174). StuddyBuddy aggregates publicly available trial information.