Choline to Improve Malnutrition and Enhance Cognition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-59
SponsorWashington University School of Medicine
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- C-RUTF (Ready-to-Use Therapeutic Food with added choline)
- S-RUTF (Ready-to-Use Therapeutic Food without added choline)
- Amoxicillin
Treatment groups
1,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
Project Peanut Butter
Collaborator
Kamuzu University of Health Sciences
Collaborator
Balchem Corporation
Collaborator
Source ClinicalTrials.gov