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NCT Number: NCT06657677

Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses

Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin, as well as its protein characteristics, following the administration of a single iron dose

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich, Zurich, Canton of Zurich, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Low iron stores (SF levels < 30 µg/L),
  • no anemia (Hb > 120 g/L)
  • no inflammation (CRP < 5 mg/L)
  • 18 to 45 years old.
  • Body weight <70 kg
  • Normal body Mass Index (18.5-26.5 kg/m2)

Exclusion criteria

  • Any chronic or acute disease
  • Consumption of mineral and vitamin supplements since screening and over the study period
  • Blood transfusion, blood donation or significant blood loss over the past 6 months,
  • Pregnant or breastfeeding,
  • Continuous/long-term use of medication during the whole studies (except for contraceptives)
  • Therapeutic iron infusion over the past 6 months,
  • Known hypersensitivity or allergy to iron supplements,
  • Intention to become pregnant over the course of the study

Treatment and study plan

40mg oral iron dosing

Dietary Supplement

Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate

100mg oral iron dosing

Dietary Supplement

Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate

180mg oral iron dosing

Dietary Supplement

Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate

Primary outcomes

  1. Serum ferritin

    Time frame: study day 1

    Serum ferritin concentration

  2. Serum ferritin

    Time frame: study day 7

    Serum ferritin concentration

Secondary outcomes

  1. C-reactive protein

    Time frame: study day 0

    C-reactive protein concentration in serum

  2. Serum ferritin

    Time frame: study day 0

    Serum ferritin concentration

  3. Serum ferritin

    Time frame: study day 6

    Serum ferritin concentration

  4. Serum ferritin

    Time frame: study day 14

    Serum ferritin concentration

  5. Serum ferritin

    Time frame: study day 5

    Serum ferritin concentration

  6. Serum ferritin

    Time frame: study day 4

    Serum ferritin concentration

  7. Serum ferritin

    Time frame: study day 3

    Serum ferritin concentration

  8. Serum ferritin

    Time frame: study day 2

    Serum ferritin concentration

  9. alpha(1)-acid-glycoprotein

    Time frame: study day 0

    alpha(1)-acid-glycoprotein concentration in serum

  10. soluble transferrin receptor

    Time frame: study day 0

    soluble transferrin receptor in serum

  11. Hemoglobin

    Time frame: study day 0

    Hemoglobin concentration

  12. Serum iron

    Time frame: study day 0

    serum iron concentration in circulation

  13. Serum iron

    Time frame: study day 1

    serum iron concentration in circulation

  14. Serum iron

    Time frame: study day 2

    serum iron concentration in circulation

  15. Serum iron

    Time frame: study day 3

    serum iron concentration in circulation

  16. Serum iron

    Time frame: study day 4

    serum iron concentration in circulation

  17. Serum iron

    Time frame: study day 5

    serum iron concentration in circulation

  18. Serum iron

    Time frame: study day 6

    serum iron concentration in circulation

  19. Serum iron

    Time frame: study day 7

    serum iron concentration in circulation

  20. Serum iron

    Time frame: study day 14

    serum iron concentration in circulation

  21. Isotopic composition of Serum Ferritin

    Time frame: study day 0

    shift in stable iron isotopes in serum ferritin

  22. Isotopic composition of Serum Ferritin

    Time frame: study day 2

    shift in stable iron isotopes in serum ferritin

  23. Isotopic composition of Serum Ferritin

    Time frame: study day 7

    shift in stable iron isotopes in serum ferritin

  24. Structural characteristics of Serum Ferritin

    Time frame: study day 0

    Proteomics

  25. Structural characteristics of Serum Ferritin

    Time frame: study day 2

    Proteomics

  26. Structural characteristics of Serum Ferritin

    Time frame: study day 7

    Proteomics

  27. Fractional iron absorption

    Time frame: study day 14

    Erythrocyte iron incorporation of stable iron isotope

Sponsors and collaborators

Lead sponsor

Jessica Rigutto

Other

Registry information

Official study title

Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2024
Registry last updated
Feb 27, 2025

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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