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NCT Number: NCT04008147

Hepcidin and Glucose Metabolism

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.

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Key information

Conditions

Iron Deficiency Anemia of Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Laboratory ETH Zurich

Zurich, 8092, Switzerland

Location status: Recruiting

Location contact

Nicole U Stoffel, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • week of pregnancy 24-28
  • pre-pregnancy BMI <27.5kg/m2
  • singleton pregnancy
  • Hb > 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

  • iron infusion within the past 6 months
  • severely anemic Hb<8.0g/dl
  • acute or chronic disease
  • long-term medication
  • medical problems known to affect iron homeostasis
  • smoking

Treatment and study plan

100mg iron fumarate

Dietary Supplement

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

Burgerstein Schwangerschaft & Stillzeit

Dietary Supplement

contains 30 mg iron fumarate, given on 14 consecutive days

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

Study contacts

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

Nicole U Stoffel, PhD

CONTACT

[email protected]

+41 44 632 83 93

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • University Hospital, Zürich

Registry information

Official study title

The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Pregnancy

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2019
Registry last updated
May 22, 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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