Choline supplementation to prevent severe malnutrition in children
An Individually Randomized, Partially Blinded, Controlled Trial of Choline-containing Ready-to-use Supplementary Food (C-RUSF) for Children With Moderate Acute Malnutrition to Reduce Deterioration to Severe Acute Malnutrition Compared to Standard RUSF.
This study is testing if adding choline to special food can help young children in Malawi with moderate malnutrition avoid getting worse and becoming severely malnourished.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 10 sites (Chikonde and 9 other locations) |
| Trial ID | NCT06214897 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of choline supplementation in children aged 6-59 months with moderate acute malnutrition (MAM) in Malawi. Participants will receive ready-to-use supplemental food (RUSF) with added choline (500mg/day) for up to 12 weeks, compared to standard RUSF without choline. The study seeks to determine if this intervention can reduce the risk of deterioration to severe acute malnutrition (SAM) among these children. Given the high prevalence of MAM and its associated risks, this trial addresses a critical public health issue.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-59 months diagnosed with uncomplicated moderate acute malnutrition.
Not a fit: Patients with complicated MAM or those with chronic severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of severe acute malnutrition in vulnerable children.
How similar studies have performed: While there is growing evidence supporting the role of choline in nutrition, this specific approach to prevent SAM in children with MAM is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Chikonde and 9 other locations
- Chikonde Health Center — Chikonde, Malawi (Recruiting)
- Chipolonga Health Center — Chipolonga, Malawi (Recruiting)
- Makhwira Health Center — Makhwira, Malawi (Recruiting)
- Mbiza Health Clinic — Mbiza, Malawi (Recruiting)
- Milonde Health Center — Milonde, Malawi (Recruiting)
- Mitondo Health Center — Mitondo, Malawi (Recruiting)
- Muloza Health Clinic — Muloza, Malawi (Recruiting)
- Namasalima Health Center — Namasalima, Malawi (Recruiting)
- Naphimba Health Center — Naphimba, Malawi (Recruiting)
- Nkhate Health Clinic — Nkhate, Malawi (Recruiting)
Study contacts
- Principal investigator: Mark J Manary, MD — Washington University School of Medicine
- Study coordinator: Mark J Manary, MD
- Email: manarymj@wustl.edu
- Phone: 314-454-2178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.