Using choline to enhance cognitive development in malnourished children

Choline to Improve Malnutrition and Enhance Cognition

This study is testing if adding choline to special food for severely malnourished children in Malawi can help improve their thinking skills as they recover.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 6 Months to 59 Months
• Sex: All
• Sponsor: Washington University School of Medicine (other)
• Locations: 10 sites (Makhwira, Chikwawa and 9 other locations)
• Trial ID: NCT06154174 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of adding a daily dose of choline to ready-to-use therapeutic food (RUTF) for children suffering from severe acute malnutrition (SAM) in Malawi. The study will compare cognitive development outcomes in children aged 6-59 months receiving RUTF with and without choline supplementation. By addressing the nutritional deficiencies associated with SAM, the trial seeks to improve both immediate recovery and long-term cognitive outcomes. The research builds on previous findings that suggest modifications to RUTF can enhance cognitive recovery.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6-59 months diagnosed with severe acute malnutrition.

Not a fit: Patients with complicated severe acute malnutrition or those with chronic severe medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve cognitive development in children recovering from severe acute malnutrition.

How similar studies have performed: Previous studies have shown success with similar nutritional interventions, indicating potential for positive outcomes in this trial.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Makhwira, Chikwawa and 9 other locations

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

Study contacts

• Principal investigator: Mark J Manary, MD — Washington University School of Medicine
• Study coordinator: Mark J Manary, MD

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