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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
C-RUTF (Ready-to-Use Therapeutic Food with added choline)
Dietary supplementCholine added to peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications
S-RUTF (Ready-to-Use Therapeutic Food without added choline)
Dietary supplementStandard peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications
Amoxicillin
DrugOral amoxicillin tablets twice per day for 7 days dosed based on weight
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: C-RUTF (Ready-to-Use Therapeutic Food with added choline)Experimental treatment 2 interventions
Group B: S-RUTF (Ready-to-Use Therapeutic Food without added choline)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Malawi Developmental Assessment Tool global z-score
Age-standardized score, -6 to +6, higher scores are better
Time frame
6 months after SAM outcomeSecondary outcomes
1
Malawi Developmental Assessment Tool gross motor sub-domain z-score
Age-standardized score, -6 to +6, higher scores are better
Time frame
6 months after SAM outcome2
Malawi Developmental Assessment Tool fine motor sub-domain z-score
Age-standardized score, -6 to +6, higher scores are better
Time frame
6 months after SAM outcome3
Malawi Developmental Assessment Tool language sub-domain z-score
Age-standardized score, -6 to +6, higher scores are better
Time frame
6 months after SAM outcome4
Malawi Developmental Assessment Tool social sub-domain z-score
Age-standardized score, -6 to +6, higher scores are better
Time frame
6 months after SAM outcomeOther outcomes
1
MDAT global z-score by age
Subgroups: enrollment \<12 vs. \>=12 months of age, -6 to +6, higher scores are better
Time frame
6-month post-outcome MDAT visit2
MDAT global z-score by SAM outcome status
Subgroups: Recovered vs. Other, -6 to +6, higher scores are better
Time frame
6-month post-outcome MDAT visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
Project Peanut Butter
Collaborator
Kamuzu University of Health Sciences
Collaborator
Balchem Corporation
Collaborator
Source ClinicalTrials.gov