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Choline to Improve Malnutrition and Enhance Cognition

NCT06154174 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-03-17

No results posted yet for this study

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?

Conditions

Interventions

DIETARY_SUPPLEMENT

S-RUTF (Ready-to-Use Therapeutic Food without added choline)

Standard peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications

DIETARY_SUPPLEMENT

C-RUTF (Ready-to-Use Therapeutic Food with added choline)

Choline added to peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications

DRUG

Amoxicillin

Oral amoxicillin tablets twice per day for 7 days dosed based on weight

Sponsors & Collaborators

  • Project Peanut Butter

    collaborator OTHER

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • Balchem Corporation

    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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

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 NCT06154174 on ClinicalTrials.gov