Skip to main content
OpenTrials
Completed

NCT Number: NCT05266703

Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption

The serum or plasma ferritin concentration (referred to hereafter as ferritin) is the most widely used indicator to detect iron deficiency and a low ferritin indicates depleted iron stores. However, the threshold ferritin that defines iron deficiency remains unclear and diagnostic ferritin cutoffs from expert groups vary widely.

Our study aim is to define the ferritin in Kenyan young women at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in Sub-Saharan African women.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Ferritin Threshold Hematologic Diseases Hemic and Lymphatic Diseases Iron Absorption Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Stable Iron Isotopes

Age range

18 year–28 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Msambweni County Referral Hospital

Msambweni, Kenya

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-28 y, not pregnant or lactating
  • Body weight <75 kg
  • body mass index (BMI) between 17 and 25 kg/m2
  • No acute illness/infection (self-reported)
  • No metabolic or gastrointestinal disorders (self-reported)
  • No use of medications affecting iron absorption or metabolism during the study
  • No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study

Treatment and study plan

Isotopically labelled iron sulfate 15mg

Other

test drink: water containing isotopic iron solution with vitamin C

Primary outcomes

  1. Fractional iron absorption

    Time frame: Day 14

    shift in iron isotopic ratios measured in red blood cells

Secondary outcomes

  1. Plasma Ferritin

    Time frame: Day 0

  2. Plasma Ferritin

    Time frame: 4 months after isotope administration

  3. Plasma Ferritin

    Time frame: 8 months after isotope administration

  4. Plasma Ferritin

    Time frame: 12 months after isotope administration

  5. soluble transferrin receptor

    Time frame: Day 0

  6. soluble transferrin receptor

    Time frame: 4 months after isotope administration

  7. soluble transferrin receptor

    Time frame: 8 months after isotope administration

  8. soluble transferrin receptor

    Time frame: 12 months after isotope administration

  9. C-reactive protein

    Time frame: Day 0

  10. C-reactive protein

    Time frame: 4 months after isotope administration

  11. C-reactive protein

    Time frame: 8 months after isotope administration

  12. C-reactive protein

    Time frame: 12 months after isotope administration

  13. alpha-1-glycoprotein

    Time frame: Day 0

  14. alpha-1-glycoprotein

    Time frame: 4 months after isotope administration

  15. alpha-1-glycoprotein

    Time frame: 8 months after isotope administration

  16. alpha-1-glycoprotein

    Time frame: 12 months after isotope administration

  17. Hemoglobin

    Time frame: Day 0

  18. Hemoglobin

    Time frame: 4 months after isotope administration

  19. Hemoglobin

    Time frame: 8 months after isotope administration

  20. Hemoglobin

    Time frame: 12 months after isotope administration

  21. Plasma Hepcidin

    Time frame: Day 0

  22. Isotopic composition of red blood cells

    Time frame: 4 months after isotope administration

    shift in iron isotopic ratios measured in red blood cells

  23. Isotopic composition of red blood cells

    Time frame: 8 months after isotope administration

    shift in iron isotopic ratios measured in red blood cells

  24. Isotopic composition of red blood cells

    Time frame: 12 months after isotope administration

    shift in iron isotopic ratios measured in red blood cells

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Jomo Kenyatta University of Agriculture and Technology

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2022
Registry last updated
Jan 25, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.