Status:
RECRUITING
Choline to Improve Malnutrition and Enhance Cognition
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Project Peanut Butter
Kamuzu University of Health Sciences
Conditions:
Severe Acute Malnutrition
Cognitive Impairment
Eligibility:
All Genders
6-59 years
Phase:
NA
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: \...
Detailed Description
Severe acute malnutrition (SAM) affects approximately 14 million children worldwide at any one time and has an annual incidence of 3-5x this number. SAM is defined by wasting (mid-upper arm circumfere...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06154174
Start Date
December 5 2023
End Date
June 1 2026
Last Update
December 17 2025
Active Locations (10)
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1
Makhwira
Makhwira, Chikwawa, Malawi
2
Mitondo
Mitondo, Chikwawa, Malawi
3
Nkhate
Nkhate, Chikwawa, Malawi
4
Chipolonga
Chipolonga, Machinga, Malawi