Improving ready-to-use therapeutic foods to help malnourished Kenyan children absorb iron
Maximizing the Benefits of Iron in Ready-to-use Therapeutic Foods for Malnourished Children in Kenya
This project will test whether changing the iron in ready-to-use therapeutic foods helps severely malnourished Kenyan children absorb iron better and recover from anemia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 12 Months to 54 Months |
| Sex | All |
| Sponsor | ETH Zurich Academic / other |
| Locations | 2 sites (Msambweni, Kwale County and 1 other locations) |
| Trial ID | NCT07315295 on ClinicalTrials.gov |
What this trial studies
The project compares fractional iron absorption from ready-to-use therapeutic foods (RUTFs) between healthy children and children with severe acute malnutrition, and follows malnourished children through an 80-day RUTF treatment. Stable isotopes will be used to measure fractional iron absorption on day 0 and again on days 20, 40 and 60 to track changes over time. Clinical visits and feeding will occur at a research facility in Msambweni, Kwale County, with biochemical analyses performed in Zurich. The aim is to pinpoint whether current RUTF formulations or absorption deficits explain limited impact on anemia and to inform safer, more effective formulations.
Who should consider this trial
Good fit: Ideal candidates are children with severe or moderate acute malnutrition (WHZ < -3.0 for SAM or < -2.0 for MAM) who are clinically stable outpatients, pass an appetite test, and do not have severe anemia (hemoglobin >7 g/dL).
Not a fit: Children with severe anemia (hemoglobin ≤7 g/dL) or acute medical conditions requiring inpatient care are unlikely to benefit or be eligible for this project.
Why it matters
Potential benefit: If successful, the project could lead to safer, more effective RUTF formulations that reduce anemia and iron-related diarrheal risk in severely malnourished children.
How similar studies have performed: Similar work has used stable isotopes to measure iron absorption and some modified RUTFs have shown improved iron outcomes elsewhere, but results are mixed and applying this approach specifically in Kenyan SAM children is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: malnourished children: * severe acute malnutrition (SAM): WHZ \< -3.0 * moderate acute malnutrition (MAM): WHZ \< -2.0 a * treated as outpatients (no acute medical conditions and a positive appetite test) healthy children: \- healthy: HAZ, WAZ and WHZ = 0 Exclusion Criteria (both groups): * Hemoglobin ≤7 g/dL * Presence of acute medical conditions requiring inpatient management
Where this trial is running
Msambweni, Kwale County and 1 other locations
- ETH/Oxford/JKUAT research facility — Msambweni, Kwale County, Kenya (Recruiting)
- ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092 — Zurich, Switzerland (Not_yet_recruiting)
Study contacts
- Study coordinator: Suzane Nyilima, MSc
- Email: suzane.nyilima@gmail.com
- Phone: +254702836210
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.