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NCT Number: NCT07315295

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.

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Key information

Conditions

Iron Absorption Anemia Child Nutrition Disorders Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Malnutrition Malnutrition in Children Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Severe Acute Malnutrition Severly Acutely Malnourished Children

Age range

12 month–54 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ETH/Oxford/JKUAT research facility, Msambweni, Kwale County, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron absorption from RUTF on Day 0

Other

RUFT with 57Fe

Treatment with RUTF for 80 days

Dietary Supplement

Daily RUTF intake

Iron absorption from RUTF on Day 20

Other

RUFT with 57Fe

Iron absorption from RUTF on Day 40

Other

RUFT with 57Fe

Iron absorption from RUTF on Day 60

Other

RUFT with 57Fe

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

    Time frame: Day 0

    Iron status parameter

  2. Hemoglobin

    Time frame: Day 20

    Iron status parameter

  3. Hemoglobin

    Time frame: Day 40

    Iron status parameter

  4. Hemoglobin

    Time frame: Day 60

    Iron status parameter

  5. Hemoglobin

    Time frame: Day 80

    Iron status parameter

  6. Serum ferritin

    Time frame: Day 0

    Iron status parameter

  7. Serum Ferritin

    Time frame: Day 20

    Iron status parameter

  8. Serum Ferritin

    Time frame: Day 40

    Iron status parameter

  9. Serum Ferritin

    Time frame: Day 60

    Iron status parameter

  10. soluble transferrin receptor

    Time frame: Day 0

    Iron status parameter

  11. soluble transferrin receptor

    Time frame: Day 20

    Iron status parameter

  12. soluble transferrin receptor

    Time frame: Day 40

    Iron status parameter

  13. soluble transferrin receptor

    Time frame: Day 60

    Iron status parameter

  14. C-reactive protein

    Time frame: Day 0

    inflammation status parameter

  15. C-reactive protein

    Time frame: Day 20

    inflammation status parameter

  16. C-reactive protein

    Time frame: Day 40

    inflammation status parameter

  17. C-reactive protein

    Time frame: Day 60

    inflammation status parameter

  18. α₁-acid glycoprotein

    Time frame: Day 0

    inflammation status parameter

  19. α₁-acid glycoprotein

    Time frame: Day 20

    inflammation status parameter

  20. α₁-acid glycoprotein

    Time frame: Day 40

    inflammation status parameter

  21. α₁-acid glycoprotein

    Time frame: Day 60

    inflammation status parameter

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Suzane Nyilima, MSc

CONTACT

[email protected]

+254702836210

Sponsors and collaborators

Lead sponsor

ETH Zurich

Other

Registry information

Acronym: SAMI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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