Actively Recruiting

Phase Not Applicable
Age: 6Months - 59Months
All Genders
NCT06154174

Choline to Improve Malnutrition and Enhance Cognition

Led by Washington University School of Medicine · Updated on 2026-03-17

1500

Participants Needed

10

Research Sites

151 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

P

Project Peanut Butter

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Choline to Improve Malnutrition and Enhance Cognition

Who Can Participate

Age: 6Months - 59Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 59 months
  • Mid-upper arm circumference less than 11.5 cm and/or weight-for-length z-score below -3 and/or presence of bilateral pedal pitting edema
  • Willingness to follow all study procedures and availability for the entire study duration, including no plans to move from the local clinic area
Not Eligible

You will not qualify if you...

  • Complicated severe acute malnutrition requiring immediate hospitalization or inability to tolerate a 30g test dose of RUTF
  • Participation in another feeding program within the past month
  • Known allergy to peanut, milk, or fish ingredients in study food
  • Intention to move away from the study area within 9 months
  • Developmental delay
  • Presence of a chronic severe medical condition other than tuberculosis or HIV, such as congenital heart disease

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Makhwira

Makhwira, Chikwawa, Malawi

Actively Recruiting

2

Mitondo

Mitondo, Chikwawa, Malawi

Actively Recruiting

3

Nkhate

Nkhate, Chikwawa, Malawi

Actively Recruiting

4

Chipolonga

Chipolonga, Machinga, Malawi

Actively Recruiting

5

Chikonde

Chikonde, Mulanje, Malawi

Actively Recruiting

6

Mbiza

Mbiza, Mulanje, Malawi

Actively Recruiting

7

Milonde

Milonde, Mulanje, Malawi

Actively Recruiting

8

Muloza

Muloza, Mulanje, Malawi

Actively Recruiting

9

Namasalima

Namasalima, Mulanje, Malawi

Actively Recruiting

10

Naphimba

Naphimba, Mulanje, Malawi

Actively Recruiting

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Research Team

M

Mark J Manary, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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