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Iron Deficiency Without AnemiaINFER 2NCT06851130

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

A study testing ferrous sulfate 80 mg and ferrous sulfate 160 mg in people with Iron Deficiency Without Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Iron Deficiency Without Anemia
What is being tested?
ferrous sulfate 80 mg and ferrous sulfate 160 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSwitzerland
Study dates
25 Feb 2025to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicole Stoffel, PhD contact

+41 44 632 83 93

nicole.stoffel@hest.ethz.ch

Switzerland1 site, 1 recruiting

  • Laboratory of Nutrition and Metabolic Epigenetics

    Zurich, Canton of Zurich, 8092

    Gian Tizio Rosalen, MSc, +41446328393, giantizio.rosalen@hest.ethz.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Being tested
ferrous sulfate 80 mg, ferrous sulfate 160 mg
Keywords
serum ferritin, oral iron supplementation
Medical subject headings
Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ferrous sulfate 80 mgDietary supplement

    1 tablet per day

  • ferrous sulfate 160 mgDietary supplement

    2 tablets per day

Study groups in NCT06851130
Study groupRoleWhat they receive
80 mgExperimentalDaily dose of 80 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).
Receives: Dietary Supplement: ferrous sulfate 80 mg
160ExperimentalDaily dose of 160 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).
Receives: Dietary Supplement: ferrous sulfate 160 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 31

  2. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 37

  3. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 68

  4. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 74

Secondary outcomes (74)

  1. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 1

  2. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 30

  3. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 67

  4. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 20

  5. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 36

  6. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 57

  7. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 72

  8. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 71

  9. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 70

  10. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 69

  11. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 73

  12. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 47

  13. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 35

  14. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 34

  15. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 33

  16. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 32

  17. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 10

  18. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 6

  19. Serum ferritin

    Serum ferritin concentration

    Measured: Study day 3

  20. Serum Ferritin

    Serum Ferritin concentration

    Measured: Study Day 1

  21. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 1

  22. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 1

  23. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 3

  24. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 6

  25. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 10

  26. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 20

  27. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 30

  28. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 31

  29. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 32

  30. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 33

  31. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 34

  32. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 35

  33. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 36

  34. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 37

  35. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 47

  36. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 57

  37. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 67

  38. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 68

  39. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 69

  40. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 70

  41. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 71

  42. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 72

  43. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 73

  44. C-reactive protein

    C-reactive protein concentration in serum

    Measured: Study day 74

  45. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 3

  46. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 6

  47. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 10

  48. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 20

  49. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 30

  50. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 31

  51. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 32

  52. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 33

  53. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 34

  54. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 35

  55. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 36

  56. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 37

  57. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 47

  58. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 57

  59. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 67

  60. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 68

  61. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 69

  62. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 70

  63. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 71

  64. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 72

  65. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 73

  66. alpha(1)-acid-glycoprotein

    alpha(1)-acid-glycoprotein concentration in serum

    Measured: Study day 74

  67. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 10

  68. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 20

  69. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 30

  70. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 37

  71. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 47

  72. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 57

  73. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 67

  74. Hemoglobin

    Hemoglobin concentration

    Measured: Study day 74

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start25 Feb 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06851130
Sponsor's protocol ID
INFER Study 2
Acronym
INFER 2
Status last verified
May 2025
First submitted
24 Feb 2025
Last updated
20 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ferrous sulfate 80 mg and ferrous sulfate 160 mg in people with Iron Deficiency Without Anemia, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicole Stoffel, PhD (+41 44 632 83 93, nicole.stoffel@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum ferritin (time frame: Study day 31). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06851130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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