Choline to Improve Malnutrition and Enhance Cognition

Recruiting now · Not applicable

Conditions studied: Severe Acute Malnutrition, Cognitive Impairment, Wasting, Kwashiorkor

In brief

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 facts

Study ID

NCT06154174

Run by

Washington University School of Medicine

People needed

1500

Starts

2023-12-05

Expected to finish

2026-11-01

Last updated by the study team

2026-03-17

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 6-59 months of age
• mid-upper arm circumference < 11.5 cm and/or weight-for-length z-score < -3 and/or presence of bilateral pedal pitting edema
• willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic

You may not qualify if…

• features of complicated SAM: inability to tolerate a 30g test dose of RUTF, breathing difficulties, mental status changes, sepsis, or physician/nursing clinical assessment that the child needs immediate hospitalization
• participation in a separate feeding program within the past month
• known allergy to study food ingredient (peanut, milk, fish)
• intention to move away from catchment area within 9 months
• developmental delay
• presence of a chronic severe medical condition (other than TB and HIV), such as congenital heart disease

Where it is running

• Makhwira — Makhwira, Chikwawa, Malawi (enrolling)
• Mitondo — Mitondo, Chikwawa, Malawi (enrolling)
• Nkhate — Nkhate, Chikwawa, Malawi (enrolling)
• Chipolonga — Chipolonga, Machinga, Malawi (enrolling)
• Chikonde — Chikonde, Mulanje, Malawi (enrolling)
• Mbiza — Mbiza, Mulanje, Malawi (enrolling)
• Milonde — Milonde, Mulanje, Malawi (enrolling)
• Muloza — Muloza, Mulanje, Malawi (enrolling)
• Namasalima — Namasalima, Mulanje, Malawi (enrolling)
• Naphimba — Naphimba, Mulanje, Malawi (enrolling)

Full record on ClinicalTrials.gov

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