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Recruiting NCT07315295

NCT07315295 Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya

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Clinical Trial Summary
NCT ID NCT07315295
Status Recruiting
Phase
Sponsor ETH Zurich
Condition Iron Absorption
Study Type INTERVENTIONAL
Enrollment 68 participants
Start Date 2025-12-23
Primary Completion 2026-06-30

Eligibility & Interventions

Sex All sexes
Min Age 12 Months
Max Age 54 Months
Study Type INTERVENTIONAL
Interventions
Iron absorption from RUTF on Day 0Treatment with RUTF for 80 daysIron absorption from RUTF on Day 20

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 68 participants in total. It began in 2025-12-23 with a primary completion date of 2026-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Reports from the Kenya Red Cross Society (KRCS) in Kwale County, southern Kenya, indicate a limited impact of Ready-to-Use Therapeutic Foods (RUTFs) on malnutrition or anemia. The current RUTF formulation may have an excessively high iron content. In severely acutely malnourished (SAM) children, iron cannot be properly absorbed, leading to life-threatening diarrhea. The overall aim of this project is to develop an improved RUTF treatment that addresses acute malnutrition and anemia in children, ensuring both safety and efficacy. Specifically, to assess the impact of malnutrition on fractional iron absorption (FIA) from RUTFs in children, by comparing healthy children to those with acute malnutrition and by tracking changes in FIA in malnourished children over the course of treatment.

Eligibility 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

Contact & Investigator

Central Contact

Suzane Nyilima, MSc

✉ suzane.nyilima@gmail.com

📞 +254702836210

Frequently Asked Questions

Who can join the NCT07315295 clinical trial?

This trial is open to participants of all sexes, aged 12 Months or older, up to 54 Months, studying Iron Absorption. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07315295 currently recruiting?

Yes, NCT07315295 is actively recruiting participants. Contact the research team at suzane.nyilima@gmail.com for enrollment information.

Where is the NCT07315295 trial being conducted?

This trial is being conducted at Msambweni, Kenya, Zurich, Switzerland.

Who is sponsoring the NCT07315295 clinical trial?

NCT07315295 is sponsored by ETH Zurich. The trial plans to enroll 68 participants.

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