Choline to Improve Malnutrition and Enhance Cognition
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Malawi
Chikonde
RECRUITING
Chikonde
Chipolonga
RECRUITING
Chipolonga
Makhwira
RECRUITING
Makhwira
Mbiza
RECRUITING
Mbiza
Milonde
RECRUITING
Milonde
Mitondo
RECRUITING
Mitondo
Muloza
RECRUITING
Muloza
Namasalima
RECRUITING
Namasalima
Naphimba
RECRUITING
Naphimba
Nkhate
RECRUITING
Nkhate
Contact Information
Primary
Mark J Manary, MD
manarymj@wustl.edu
+1 314-454-2341
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2026-03
Participants
Target number of participants: 1500
Treatments
Experimental: C-RUTF (Ready-to-Use Therapeutic Food with added choline)
A daily dose of 500mg choline will be added to RUTF. 2 sachets (daily dose) of RUTF will provide approximately 1000 Kcal, 14g of protein, 28g of fat, and 1 RDA of 14 micronutrients.
Active_comparator: S-RUTF (Ready-to-Use Therapeutic Food without added choline)
A daily dose of 5mg choline will be added to RUTF for masking. 2 sachets (daily dose) of RUTF will provide approximately 1000 Kcal, 14g of protein, 28g of fat, and 1 RDA or 14 micronutrients.
Related Therapeutic Areas
Sponsors
Collaborators: Project Peanut Butter, Kamuzu University of Health Sciences, Balchem Corporation
Leads: Washington University School of Medicine