RecruitingNot ApplicableNCT07315295

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

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


Sponsor

ETH Zurich

Enrollment

68 participants

Start Date

Dec 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 MonthsMax Age: 54 Months

Inclusion Criteria6

  • 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 Criteria2

  • Hemoglobin ≤7 g/dL
  • Presence of acute medical conditions requiring inpatient management

Interventions

OTHERIron absorption from RUTF on Day 0

RUFT with 57Fe

DIETARY_SUPPLEMENTTreatment with RUTF for 80 days

Daily RUTF intake

OTHERIron absorption from RUTF on Day 20

RUFT with 57Fe

OTHERIron absorption from RUTF on Day 40

RUFT with 57Fe

OTHERIron absorption from RUTF on Day 60

RUFT with 57Fe


Locations(2)

ETH/Oxford/JKUAT research facility

Msambweni, Kwale County, Kenya

ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092

Zurich, Switzerland

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NCT07315295


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