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RecruitingNCT04008147Updated May 22, 2025

Hepcidin and Glucose Metabolism

An interventional study of 100mg iron fumarate and Burgerstein Schwangerschaft & Stillzeit in Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders and Glucose Intolerance, sponsored by Swiss Federal Institute of Technology. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2019; still recruiting 7 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Gestational diabetes mellitus (GDM), defined as hyperglycemia with blood glucose values above normal but below those diagnostic of DM, and iron deficiency (ID) with or without anemia (IDA) are common during pregnancy. Both disease patterns are associated with an increased risk of complications during pregnancy and at delivery and may have a variety of negative effects on different aspects of child development. Thus, GDM and ID/IDA during pregnancy should be prevented.

Whether iron supplementation with high oral doses acutely increases hepcidin during pregnancy, and whether this acute iron-induced increase in hepcidin decreases insulin sensitivity, is uncertain.

02

Conditions studied

  • Iron Deficiency Anemia of Pregnancy
  • Iron Metabolism Disorders
  • Glucose Intolerance
  • Gestational Diabetes
03

In context

Iron Metabolism Disorders

20 studies on the registry are indexed under Iron Metabolism Disorders; 6 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 13 interventional studies indexed under Iron Metabolism Disorders.

Browse Iron Metabolism Disorders studies →

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Browse Swiss Federal Institute of Technology studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • week of pregnancy 24-28
  • pre-pregnancy \<27.5kg/m2
  • singleton pregnancy
  • > 8.0 g/dl

Willing to either:

  • not take any iron supplements for 14 days (however, participants will receive a similar amount of total iron during the 4 study days that they would normally receive over 14 days) OR
  • to take the multivitamin "Burgerstein Schwangerschaft and Stillzeit" supplements over the 14 days (contains 30 mg iron)

Exclusion criteria

Exclusion Criteria:

  • iron infusion within the past 6 months
  • severely anemic \<8.0g/dl
  • acute or chronic disease
  • long-term medication
  • medical problems known to affect iron homeostasis
  • smoking
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    High Iron Group

    15 women taking 100 mg iron twice daily for 4 days (800 mg).

    Dietary Supplement: 100mg iron fumarate

  • Active comparator
    Low Iron Group

    15 women taking 30 mg iron once daily for 14 days (420 mg).

    Dietary Supplement: Burgerstein Schwangerschaft & Stillzeit

Interventions

  • Dietary supplement100mg iron fumarate

    100mg iron fumarate b.i.d. for 4 consecutive days

  • Dietary supplementBurgerstein Schwangerschaft & Stillzeit

    contains 30 mg iron fumarate, given on 14 consecutive days

06

What researchers measure

Primary outcomes

  1. Serum hepcidin

    Time frame: before OGTT, 1 day before high/low iron supplementation

  2. Serum hepcidin

    Time frame: after OGTT, 1 day before high/low iron supplementation

  3. Serum hepcidin

    Time frame: before OGTT, after high/low iron supplementation at day 7

  4. Serum hepcidin

    Time frame: after OGTT, after high/low iron supplementation at day 7

  5. Serum iron

    Time frame: before OGTT, 1 day before high/low iron supplementation

  6. Serum iron

    Time frame: after OGTT, 1 day before high/low iron supplementation

  7. Serum iron

    Time frame: before OGTT, after high/low iron supplementation at day 7

  8. Serum iron

    Time frame: after OGTT, after high/low iron supplementation at day 7

  9. glucose

    Time frame: before OGTT, 1 day before high/low iron supplementation

  10. glucose

    Time frame: after OGTT, 1 day before high/low iron supplementation

  11. glucose

    Time frame: before OGTT, after high/low iron supplementation at day 7

  12. glucose

    Time frame: after OGTT, after high/low iron supplementation at day 7

  13. insulin

    Time frame: before OGTT, 1 day before high/low iron supplementation

  14. insulin

    Time frame: after OGTT, 1 day before high/low iron supplementation

  15. insulin

    Time frame: before OGTT, after high/low iron supplementation at day 7

  16. insulin

    Time frame: after OGTT, after high/low iron supplementation at day 7

  17. Serum hepcidin

    Time frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation

  18. Serum iron

    Time frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation

  19. glucose

    Time frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation

  20. insulin

    Time frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation

Secondary outcomes

  1. Serum ferritin

    Time frame: before OGTT, 1 day before high/low iron supplementation

  2. Serum ferritin

    Time frame: after OGTT, 1 day before high/low iron supplementation

  3. Serum ferritin

    Time frame: before OGTT, after high/low iron supplementation at day 7

  4. Serum ferritin

    Time frame: after OGTT, after high/low iron supplementation at day 7

  5. soluble transferrin receptor

    Time frame: before OGTT, 1 day before high/low iron supplementation

  6. soluble transferrin receptor

    Time frame: after OGTT, 1 day before high/low iron supplementation

  7. soluble transferrin receptor

    Time frame: before OGTT, after high/low iron supplementation at day 7

  8. soluble transferrin receptor

    Time frame: after OGTT, after high/low iron supplementation at day 7

  9. c-reactive protein

    Time frame: before OGTT, 1 day before high/low iron supplementation

  10. c-reactive protein

    Time frame: after OGTT, 1 day before high/low iron supplementation

  11. c-reactive protein

    Time frame: before OGTT, after high/low iron supplementation at day 7

  12. c-reactive protein

    Time frame: after OGTT, after high/low iron supplementation at day 7

  13. alpha glycoprotein

    Time frame: before OGTT, 1 day before high/low iron supplementation

  14. alpha glycoprotein

    Time frame: after OGTT, 1 day before high/low iron supplementation

  15. alpha glycoprotein

    Time frame: before OGTT, after high/low iron supplementation at day 7

  16. alpha glycoprotein

    Time frame: after OGTT, after high/low iron supplementation at day 7

07

Study locations

1 of 1 sites recruiting
  • Human Nutrition Laboratory ETH Zurich
    Zürich, 8092, Switzerland
    Recruiting
    • Nicole U Stoffel, PhD · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2019 (actual). Primary completion is estimated for Dec 2025, 77 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2019
First posted
Jul 5, 2019
StartActual
Jul 3, 2019
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
May 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04008147
Lead sponsor
Swiss Federal Institute of Technology
Collaborators
University Hospital, Zürich
Responsible party
Isabelle Herter-Aeberli (PhD, Swiss Federal Institute of Technology) — Principal investigator
First posted
Jul 5, 2019
Start date
Jul 3, 2019
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 22, 2025

Study contacts

Nicole U Stoffel, PhD
Contact
nicole.stoffel@hest.ethz.ch
+41 44 632 83 93

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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