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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

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

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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