Iron AbsorptionSAMINCT07315295
Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya
A study testing Iron absorption from RUTF on Day 0, Treatment with RUTF for 80 days and Iron absorption from RUTF on Day 20 in people with Iron Absorption and Iron Deficiencies, run by ETH Zurich at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Absorption, Iron Deficiencies, Severly Acutely Malnourished Children
- What is being tested?
- Iron absorption from RUTF on Day 0, Treatment with RUTF for 80 days and Iron absorption from RUTF on Day 20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Dec 2025to 30 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Hemoglobin ≤7 g/dL
- Presence of acute medical conditions requiring inpatient management
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Kenya1 site, 1 recruiting
- Recruiting
ETH/Oxford/JKUAT research facility
Msambweni, Kwale County
Suzane Nyilima, +254702836210, suzane.nyilima@gmail.com
Switzerland1 site, 1 recruiting
- Not yet recruiting
ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092
Zurich, 8006
Prof. Dr. Stoffel, +41 44 632 83 93, nicole.stoffel@pharma.ethz.ch
About this study
Official title: Maximizing the Benefits of Iron in Ready-to-use Therapeutic Foods for Malnourished Children in Kenya
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.
- Conditions
- Iron Absorption, Iron Deficiencies, Severly Acutely Malnourished Children, Malnutrition in Children, Anemia
- Being tested
- 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
- Keywords
- Ready to use therapeutic foods (RUFTs), Severe acute malnutrition (SAM), Stable isotopes, Iron bioavailability
- Medical subject headings
- Iron Deficiencies, Child Nutrition Disorders, Anemia, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron absorption from RUTF on Day 0Other
RUFT with 57Fe
Treatment with RUTF for 80 daysDietary supplement
Daily RUTF intake
Iron absorption from RUTF on Day 20Other
RUFT with 57Fe
Iron absorption from RUTF on Day 40Other
RUFT with 57Fe
Iron absorption from RUTF on Day 60Other
RUFT with 57Fe
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | Active comparator | Healthy children Receives: Other: Iron absorption from RUTF on Day 0 |
| Children with MAM/SAM | Experimental | children with moderate or severe acute malnutrition Receives: Other: Iron absorption from RUTF on Day 0; Dietary Supplement: Treatment with RUTF for 80 days; Other: Iron absorption from RUTF on Day 20; Other: Iron absorption from RUTF on Day 40; Other: Iron absorption from RUTF on Day 60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Iron Absorption
Measured: Day 0
Fractional Iron Absorption
Measured: Day 20
Fractional Iron Absorption
Measured: Day 40
Fractional Iron Absorption
Measured: Day 60
Secondary outcomes (29)
Hemoglobin
Iron status parameter
Measured: Day 0
Hemoglobin
Iron status parameter
Measured: Day 20
Hemoglobin
Iron status parameter
Measured: Day 40
Hemoglobin
Iron status parameter
Measured: Day 60
Hemoglobin
Iron status parameter
Measured: Day 80
Serum ferritin
Iron status parameter
Measured: Day 0
Serum Ferritin
Iron status parameter
Measured: Day 20
Serum Ferritin
Iron status parameter
Measured: Day 40
Serum Ferritin
Iron status parameter
Measured: Day 60
soluble transferrin receptor
Iron status parameter
Measured: Day 0
soluble transferrin receptor
Iron status parameter
Measured: Day 20
soluble transferrin receptor
Iron status parameter
Measured: Day 40
soluble transferrin receptor
Iron status parameter
Measured: Day 60
C-reactive protein
inflammation status parameter
Measured: Day 0
C-reactive protein
inflammation status parameter
Measured: Day 20
C-reactive protein
inflammation status parameter
Measured: Day 40
C-reactive protein
inflammation status parameter
Measured: Day 60
α₁-acid glycoprotein
inflammation status parameter
Measured: Day 0
α₁-acid glycoprotein
inflammation status parameter
Measured: Day 20
α₁-acid glycoprotein
inflammation status parameter
Measured: Day 40
α₁-acid glycoprotein
inflammation status parameter
Measured: Day 60
body weight
Measured: Day 0
body weight
Measured: Day 20
body weight
Measured: Day 40
body weight
Measured: Day 60
body height
Measured: Day 0
body height
Measured: Day 20
body height
Measured: Day 40
body height
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start23 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETH Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Stoffel, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315295
- Sponsor's protocol ID
- SAMI
- Acronym
- SAMI
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No