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NCT Number: NCT06851130

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

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 following the administration of a daily iron dose for two months.

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Key information

Conditions

Iron Deficiency Without Anemia Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Nutrition and Metabolic Epigenetics

Zurich, Canton of Zurich, 8092, Switzerland

Location status: Recruiting

Location contact

Gian Tizio Rosalen, MSc

CONTACT

[email protected]

+41446328393

Who can participate

Healthy volunteers accepted: No

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 4 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

ferrous sulfate 80 mg

Dietary Supplement

1 tablet per day

ferrous sulfate 160 mg

Dietary Supplement

2 tablets per day

Primary outcomes

  1. Serum ferritin

    Time frame: Study day 31

    Serum ferritin concentration

  2. Serum ferritin

    Time frame: Study day 37

    Serum ferritin concentration

  3. Serum ferritin

    Time frame: Study day 68

    Serum ferritin concentration

  4. Serum ferritin

    Time frame: Study day 74

    Serum ferritin concentration

Secondary outcomes

  1. alpha(1)-acid-glycoprotein

    Time frame: Study day 1

    alpha(1)-acid-glycoprotein concentration in serum

  2. Serum ferritin

    Time frame: Study day 30

    Serum ferritin concentration

  3. Serum ferritin

    Time frame: Study day 67

    Serum ferritin concentration

  4. Serum ferritin

    Time frame: Study day 20

    Serum ferritin concentration

  5. Serum ferritin

    Time frame: Study day 36

    Serum ferritin concentration

  6. Serum ferritin

    Time frame: Study day 57

    Serum ferritin concentration

  7. Serum ferritin

    Time frame: Study day 72

    Serum ferritin concentration

  8. Serum ferritin

    Time frame: Study day 71

    Serum ferritin concentration

  9. Serum ferritin

    Time frame: Study day 70

    Serum ferritin concentration

  10. Serum ferritin

    Time frame: Study day 69

    Serum ferritin concentration

  11. Serum ferritin

    Time frame: Study day 73

    Serum ferritin concentration

  12. Serum ferritin

    Time frame: Study day 47

    Serum ferritin concentration

  13. Serum ferritin

    Time frame: Study day 35

    Serum ferritin concentration

  14. Serum ferritin

    Time frame: Study day 34

    Serum ferritin concentration

  15. Serum ferritin

    Time frame: Study day 33

    Serum ferritin concentration

  16. Serum ferritin

    Time frame: Study day 32

    Serum ferritin concentration

  17. Serum ferritin

    Time frame: Study day 10

    Serum ferritin concentration

  18. Serum ferritin

    Time frame: Study day 6

    Serum ferritin concentration

  19. Serum ferritin

    Time frame: Study day 3

    Serum ferritin concentration

  20. Serum Ferritin

    Time frame: Study Day 1

    Serum Ferritin concentration

  21. Hemoglobin

    Time frame: Study day 1

    Hemoglobin concentration

  22. C-reactive protein

    Time frame: Study day 1

    C-reactive protein concentration in serum

  23. C-reactive protein

    Time frame: Study day 3

    C-reactive protein concentration in serum

  24. C-reactive protein

    Time frame: Study day 6

    C-reactive protein concentration in serum

  25. C-reactive protein

    Time frame: Study day 10

    C-reactive protein concentration in serum

  26. C-reactive protein

    Time frame: Study day 20

    C-reactive protein concentration in serum

  27. C-reactive protein

    Time frame: Study day 30

    C-reactive protein concentration in serum

  28. C-reactive protein

    Time frame: Study day 31

    C-reactive protein concentration in serum

  29. C-reactive protein

    Time frame: Study day 32

    C-reactive protein concentration in serum

  30. C-reactive protein

    Time frame: Study day 33

    C-reactive protein concentration in serum

  31. C-reactive protein

    Time frame: Study day 34

    C-reactive protein concentration in serum

  32. C-reactive protein

    Time frame: Study day 35

    C-reactive protein concentration in serum

  33. C-reactive protein

    Time frame: Study day 36

    C-reactive protein concentration in serum

  34. C-reactive protein

    Time frame: Study day 37

    C-reactive protein concentration in serum

  35. C-reactive protein

    Time frame: Study day 47

    C-reactive protein concentration in serum

  36. C-reactive protein

    Time frame: Study day 57

    C-reactive protein concentration in serum

  37. C-reactive protein

    Time frame: Study day 67

    C-reactive protein concentration in serum

  38. C-reactive protein

    Time frame: Study day 68

    C-reactive protein concentration in serum

  39. C-reactive protein

    Time frame: Study day 69

    C-reactive protein concentration in serum

  40. C-reactive protein

    Time frame: Study day 70

    C-reactive protein concentration in serum

  41. C-reactive protein

    Time frame: Study day 71

    C-reactive protein concentration in serum

  42. C-reactive protein

    Time frame: Study day 72

    C-reactive protein concentration in serum

  43. C-reactive protein

    Time frame: Study day 73

    C-reactive protein concentration in serum

  44. C-reactive protein

    Time frame: Study day 74

    C-reactive protein concentration in serum

  45. alpha(1)-acid-glycoprotein

    Time frame: Study day 3

    alpha(1)-acid-glycoprotein concentration in serum

  46. alpha(1)-acid-glycoprotein

    Time frame: Study day 6

    alpha(1)-acid-glycoprotein concentration in serum

  47. alpha(1)-acid-glycoprotein

    Time frame: Study day 10

    alpha(1)-acid-glycoprotein concentration in serum

  48. alpha(1)-acid-glycoprotein

    Time frame: Study day 20

    alpha(1)-acid-glycoprotein concentration in serum

  49. alpha(1)-acid-glycoprotein

    Time frame: Study day 30

    alpha(1)-acid-glycoprotein concentration in serum

  50. alpha(1)-acid-glycoprotein

    Time frame: Study day 31

    alpha(1)-acid-glycoprotein concentration in serum

  51. alpha(1)-acid-glycoprotein

    Time frame: Study day 32

    alpha(1)-acid-glycoprotein concentration in serum

  52. alpha(1)-acid-glycoprotein

    Time frame: Study day 33

    alpha(1)-acid-glycoprotein concentration in serum

  53. alpha(1)-acid-glycoprotein

    Time frame: Study day 34

    alpha(1)-acid-glycoprotein concentration in serum

  54. alpha(1)-acid-glycoprotein

    Time frame: Study day 35

    alpha(1)-acid-glycoprotein concentration in serum

  55. alpha(1)-acid-glycoprotein

    Time frame: Study day 36

    alpha(1)-acid-glycoprotein concentration in serum

  56. alpha(1)-acid-glycoprotein

    Time frame: Study day 37

    alpha(1)-acid-glycoprotein concentration in serum

  57. alpha(1)-acid-glycoprotein

    Time frame: Study day 47

    alpha(1)-acid-glycoprotein concentration in serum

  58. alpha(1)-acid-glycoprotein

    Time frame: Study day 57

    alpha(1)-acid-glycoprotein concentration in serum

  59. alpha(1)-acid-glycoprotein

    Time frame: Study day 67

    alpha(1)-acid-glycoprotein concentration in serum

  60. alpha(1)-acid-glycoprotein

    Time frame: Study day 68

    alpha(1)-acid-glycoprotein concentration in serum

  61. alpha(1)-acid-glycoprotein

    Time frame: Study day 69

    alpha(1)-acid-glycoprotein concentration in serum

  62. alpha(1)-acid-glycoprotein

    Time frame: Study day 70

    alpha(1)-acid-glycoprotein concentration in serum

  63. alpha(1)-acid-glycoprotein

    Time frame: Study day 71

    alpha(1)-acid-glycoprotein concentration in serum

  64. alpha(1)-acid-glycoprotein

    Time frame: Study day 72

    alpha(1)-acid-glycoprotein concentration in serum

  65. alpha(1)-acid-glycoprotein

    Time frame: Study day 73

    alpha(1)-acid-glycoprotein concentration in serum

  66. alpha(1)-acid-glycoprotein

    Time frame: Study day 74

    alpha(1)-acid-glycoprotein concentration in serum

  67. Hemoglobin

    Time frame: Study day 10

    Hemoglobin concentration

  68. Hemoglobin

    Time frame: Study day 20

    Hemoglobin concentration

  69. Hemoglobin

    Time frame: Study day 30

    Hemoglobin concentration

  70. Hemoglobin

    Time frame: Study day 37

    Hemoglobin concentration

  71. Hemoglobin

    Time frame: Study day 47

    Hemoglobin concentration

  72. Hemoglobin

    Time frame: Study day 57

    Hemoglobin concentration

  73. Hemoglobin

    Time frame: Study day 67

    Hemoglobin concentration

  74. Hemoglobin

    Time frame: Study day 74

    Hemoglobin concentration

Study contacts

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

Nicole Stoffel, PhD

CONTACT

[email protected]

+41 44 632 83 93

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Acronym: INFER 2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
May 20, 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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