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Hepcidin and Glucose Metabolism

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04008147
Enrollment
30
Registered
2019-07-05
Start date
2019-07-03
Completion date
2025-12-31
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Glucose Intolerance, Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders

Brief 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.

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

Sponsors

University Hospital, Zürich
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
insulinbefore OGTT, 1 day before high/low iron supplementation
Serum hepcidinbefore OGTT, 1 day before high/low iron supplementation
Serum ironbefore OGTT, 1 day before high/low iron supplementation
glucosebefore OGTT, 1 day before high/low iron supplementation

Secondary

MeasureTime frame
c-reactive proteinbefore OGTT, 1 day before high/low iron supplementation
alpha glycoproteinbefore OGTT, 1 day before high/low iron supplementation
Serum ferritinbefore OGTT, 1 day before high/low iron supplementation
soluble transferrin receptorbefore OGTT, 1 day before high/low iron supplementation

Countries

Switzerland

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026