Choline to Improve Malnutrition and Enhance Cognition
CHIME-SAM
1 other identifier
interventional
1,500
1 country
10
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: \- 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2023
CompletedFirst Posted
Study publicly available on registry
December 4, 2023
CompletedStudy Start
First participant enrolled
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
March 17, 2026
March 1, 2026
2.9 years
October 18, 2023
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Malawi Developmental Assessment Tool global z-score
Age-standardized score, -6 to +6, higher scores are better
6 months after SAM outcome
Secondary Outcomes (23)
Malawi Developmental Assessment Tool gross motor sub-domain z-score
6 months after SAM outcome
Malawi Developmental Assessment Tool fine motor sub-domain z-score
6 months after SAM outcome
Malawi Developmental Assessment Tool language sub-domain z-score
6 months after SAM outcome
Malawi Developmental Assessment Tool social sub-domain z-score
6 months after SAM outcome
Malawi Developmental Assessment Tool global z-score
Within 1 month of SAM outcome
- +18 more secondary outcomes
Other Outcomes (2)
MDAT global z-score by age
6-month post-outcome MDAT visit
MDAT global z-score by SAM outcome status
6-month post-outcome MDAT visit
Study Arms (2)
C-RUTF (Ready-to-Use Therapeutic Food with added choline)
EXPERIMENTALA 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.
S-RUTF (Ready-to-Use Therapeutic Food without added choline)
ACTIVE COMPARATORA 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.
Interventions
Oral amoxicillin tablets twice per day for 7 days dosed based on weight
Standard peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications
Choline added to peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Project Peanut Buttercollaborator
- Kamuzu University of Health Sciencescollaborator
- Balchem Corporationcollaborator
Study Sites (10)
Makhwira
Makhwira, Chikwawa, Malawi
Mitondo
Mitondo, Chikwawa, Malawi
Nkhate
Nkhate, Chikwawa, Malawi
Chipolonga
Chipolonga, Machinga, Malawi
Chikonde
Chikonde, Mulanje, Malawi
Mbiza
Mbiza, Mulanje, Malawi
Milonde
Milonde, Mulanje, Malawi
Muloza
Muloza, Mulanje, Malawi
Namasalima
Namasalima, Mulanje, Malawi
Naphimba
Naphimba, Mulanje, Malawi
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark J Manary, MD
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The intervention and control RUTFs will be packaged in identical opaque sachets aside from colored stickers which will indicate randomization group. The intervention and control RUTFs will be identical in appearance, consistency, and smell. Efforts have been made to mask possible taste differences resulting from choline, including by the addition of a small amount (5mg) of choline to the control food. Participant masking cannot be guaranteed, however.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2023
First Posted
December 4, 2023
Study Start
December 5, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Within 12 months of primary publication
All collected, de-identified individual patient data