About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Hemoglobin ≤7 g/dL
Presence of acute medical conditions requiring inpatient management
Trial design
Parallel
Treatments tested in this trial
Iron absorption from RUTF on Day 0
Other interventionRUFT with 57Fe
Treatment with RUTF for 80 days
Dietary supplementDaily RUTF intake
Iron absorption from RUTF on Day 20
Other interventionRUFT with 57Fe
Iron absorption from RUTF on Day 40
Other interventionRUFT with 57Fe
Iron absorption from RUTF on Day 60
Other interventionRUFT with 57Fe
Treatment groups
Trial outcomes
Primary outcomes
Fractional Iron Absorption
Fractional Iron Absorption
Fractional Iron Absorption
Fractional Iron Absorption
Secondary outcomes
Hemoglobin
Iron status parameter
Hemoglobin
Iron status parameter
Hemoglobin
Iron status parameter
Hemoglobin
Iron status parameter