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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

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
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

In context

Iron Deficiencies

386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.

This study's planned enrollment of 68 is below the median of 99 across 301 interventional studies indexed under Iron Deficiencies.

Browse Iron Deficiencies studies →

Lead sponsor

ETH Zurich is the lead sponsor of 20 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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):

  • ≤7 g/dL
  • Presence of acute medical conditions requiring inpatient management
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

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

06

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

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2025; primary completion for Jun 2026, 6 months later.

Of 76 non-industry interventional studies with no phase under Iron Deficiencies, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's planned 6 months is below that.

Counting every sponsor, half of 88 studies reached it within 10 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2025
First posted
Jan 2, 2026
StartEst.
Dec 23, 2025
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jun 30, 2026
Last update
Jan 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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