Choline to Improve Malnutrition and Enhance Cognition
Status: Active_not_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
Chikonde
Chipolonga
Chipolonga
Makhwira
Makhwira
Mbiza
Mbiza
Milonde
Milonde
Mitondo
Mitondo
Muloza
Muloza
Namasalima
Namasalima
Naphimba
Naphimba
Nkhate
Nkhate
Time Frame
Start Date: 2023-12-05
Completion Date: 2027-01
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