Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Iron Absorption, Iron Deficiencies, Severly Acutely Malnourished Children, Malnutrition in Children. Basic parameters: 12 months — 54 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Maximizing the Benefits of Iron in Ready-to-use Therapeutic Foods for Malnourished Children in Kenya
Overview
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.
Interventions
- Other Iron absorption from RUTF on Day 0
RUFT with 57Fe - Dietary supplement Treatment with RUTF for 80 days
Daily RUTF intake - Other Iron absorption from RUTF on Day 20
RUFT with 57Fe - Other Iron absorption from RUTF on Day 40
RUFT with 57Fe - Other Iron absorption from RUTF on Day 60
RUFT with 57Fe
Primary outcome measures
- Fractional Iron Absorption [Time frame: Day 0]
- Fractional Iron Absorption [Time frame: Day 20]
- Fractional Iron Absorption [Time frame: Day 40]
- Fractional Iron Absorption [Time frame: Day 60]
Secondary outcome measures (12)
- Hemoglobin [Time frame: Day 0]
- Hemoglobin [Time frame: Day 20]
- Hemoglobin [Time frame: Day 40]
- Hemoglobin [Time frame: Day 60]
- Hemoglobin [Time frame: Day 80]
- Serum ferritin [Time frame: Day 0]
- Serum Ferritin [Time frame: Day 20]
- Serum Ferritin [Time frame: Day 40]
- Serum Ferritin [Time frame: Day 60]
- soluble transferrin receptor [Time frame: Day 0]
- soluble transferrin receptor [Time frame: Day 20]
- soluble transferrin receptor [Time frame: Day 40]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Kenya · 1 center
- ETH/Oxford/JKUAT research facility — Msambweni
Switzerland · 1 center
- ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092 — Zurich
Identifiers
NCT: NCT07315295 · SAMI