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RECRUITING
NCT06154174
NA

Choline to Improve Malnutrition and Enhance Cognition

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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?

Key Details

Gender

All

Age Range

6 Months - 59 Months

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2023-12-05

Completion Date

2026-11

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

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

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

DRUG

Amoxicillin

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

Locations (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