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RecruitingNCT07315295SAMIUpdated Jan 2, 2026

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

An interventional study of Iron absorption from RUTF on Day 0 and Treatment with RUTF for 80 days in Iron Absorption, Iron Deficiencies and Severly Acutely Malnourished Children, sponsored by ETH Zurich. Recruiting at 2 sites in 2 countries. Open to participants aged 12 Months to 54 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by ETH Zurich · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
12 Months to 54 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Iron Absorption
  • Iron Deficiencies
  • Severly Acutely Malnourished Children
  • Malnutrition in Children
  • Anemia

Keywords

  • Ready to use therapeutic foods (RUFTs)
  • Severe acute malnutrition (SAM)
  • Stable isotopes
  • Iron bioavailability
03

Who can participate

Ages eligible
12 Months to 54 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria (both groups):

  • Hemoglobin ≤7 g/dL
  • Presence of acute medical conditions requiring inpatient management
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Active comparator
    Healthy children

    Healthy children

    Other: Iron absorption from RUTF on Day 0

  • Experimental
    Children with MAM/SAM

    children with moderate or severe acute malnutrition

    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

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

05

What researchers measure

Primary outcomes

  1. Fractional Iron Absorption

    Time frame: Day 0

  2. Fractional Iron Absorption

    Time frame: Day 20

  3. Fractional Iron Absorption

    Time frame: Day 40

  4. Fractional Iron Absorption

    Time frame: Day 60

Secondary outcomes

  1. Hemoglobin

    Iron status parameter

    Time frame: Day 0

  2. Hemoglobin

    Iron status parameter

    Time frame: Day 20

  3. Hemoglobin

    Iron status parameter

    Time frame: Day 40

  4. Hemoglobin

    Iron status parameter

    Time frame: Day 60

  5. Hemoglobin

    Iron status parameter

    Time frame: Day 80

  6. Serum ferritin

    Iron status parameter

    Time frame: Day 0

  7. Serum Ferritin

    Iron status parameter

    Time frame: Day 20

  8. Serum Ferritin

    Iron status parameter

    Time frame: Day 40

  9. Serum Ferritin

    Iron status parameter

    Time frame: Day 60

  10. soluble transferrin receptor

    Iron status parameter

    Time frame: Day 0

  11. soluble transferrin receptor

    Iron status parameter

    Time frame: Day 20

  12. soluble transferrin receptor

    Iron status parameter

    Time frame: Day 40

  13. soluble transferrin receptor

    Iron status parameter

    Time frame: Day 60

  14. C-reactive protein

    inflammation status parameter

    Time frame: Day 0

  15. C-reactive protein

    inflammation status parameter

    Time frame: Day 20

  16. C-reactive protein

    inflammation status parameter

    Time frame: Day 40

  17. C-reactive protein

    inflammation status parameter

    Time frame: Day 60

  18. α₁-acid glycoprotein

    inflammation status parameter

    Time frame: Day 0

  19. α₁-acid glycoprotein

    inflammation status parameter

    Time frame: Day 20

  20. α₁-acid glycoprotein

    inflammation status parameter

    Time frame: Day 40

  21. α₁-acid glycoprotein

    inflammation status parameter

    Time frame: Day 60

  22. body weight

    Time frame: Day 0

  23. body weight

    Time frame: Day 20

  24. body weight

    Time frame: Day 40

  25. body weight

    Time frame: Day 60

  26. body height

    Time frame: Day 0

  27. body height

    Time frame: Day 20

  28. body height

    Time frame: Day 40

  29. body height

    Time frame: Day 60

06

Study locations

1 of 2 sites recruiting
  • ETH/Oxford/JKUAT research facility
    Msambweni, Kwale County, Kenya
    Recruiting
  • ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092
    Zurich, 8006, Switzerland
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07315295
Lead sponsor
ETH Zurich
Responsible party
Nicole Stoffel (Assistantprofessor, ETH Zurich) — Principal investigator
First posted
Jan 2, 2026
Start date
Dec 23, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jan 2, 2026

Study contacts

Suzane Nyilima, MSc
Contact
suzane.nyilima@gmail.com
+254702836210

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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