Status:

ACTIVE_NOT_RECRUITING

Choline to Prevent SAM in Children With MAM

Lead Sponsor:

Washington University School of Medicine

Collaborating Sponsors:

Project Peanut Butter

Kamuzu University of Health Sciences

Conditions:

Moderate Acute Malnutrition

Eligibility:

All Genders

6-59 years

Phase:

NA

Brief 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 ch...

Detailed Description

Moderate acute malnutrition (MAM) is common among children worldwide, with a prevalence of 50M and an annual incidence likely 3-5x this number. It is defined by mid-upper arm circumference (MUAC) ≥ 11...

Eligibility Criteria

Inclusion

  • 6-59 months of age
  • uncomplicated MAM (mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm and/or weight-for-length z-score (WLZ) ≥ -3 and \< -2)
  • availability for the duration of the study with no plan to move from the catchment area of a participating clinic

Exclusion

  • presence of nutritional edema
  • features of complicated MAM, such as mental status changes or breathing issues
  • participation in another feeding program
  • known allergy to study food ingredient
  • intention to move away from catchment area within 9 months
  • developmental delay
  • presence of a chronic severe medical condition (other than TB or HIV) such as congenital heart disease

Key Trial Info

Start Date :

March 18 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

1500 Patients enrolled

Trial Details

Trial ID

NCT06214897

Start Date

March 18 2024

End Date

June 1 2026

Last Update

December 17 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Chikonde Health Center

Chikonde, Malawi

2

Chipolonga Health Center

Chipolonga, Malawi

3

Makhwira Health Center

Makhwira, Malawi

4

Mbiza Health Clinic

Mbiza, Malawi