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Choline to Prevent SAM in Children With MAM

NCT06214897 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2025-12-17

No results posted yet for this study

Summary

The goal of this clinical trial is to test choline supplementation in children with moderate acute malnutrition in Malawi. The main question it aims to answer is:

Will provision of RUSF with added choline (500mg/day) throughout treatment of moderate acute malnutrition (up to 12 weeks) reduce deterioration to severe acute malnutrition among 6-59 month old Malawian children compared with standard RUSF?

Conditions

  • Moderate Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

C-RUSF (Ready-to-use Supplemental Food with added Choline)

Ready-to-use Supplemental Food with added Choline

DIETARY_SUPPLEMENT

S-RUSF (Ready-to-use Supplemental Food without added Choline)

Standard Ready-to-use Supplemental Food

Sponsors & Collaborators

  • Project Peanut Butter

    collaborator OTHER

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • Balchem Corp

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark J Manary, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214897 on ClinicalTrials.gov