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

RecruitingNAAges 12 Months - 54 MonthsAllETH Zurich
NCT07315295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Iron absorption from RUTF on Day 0
  • Treatment with RUTF for 80 days
  • Iron absorption from RUTF on Day 20
  • Iron absorption from RUTF on Day 40
  • Iron absorption from RUTF on Day 60
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Where

2 sites
ETH/Oxford/JKUAT research facility
Msambweni, Kenya
ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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