Hepcidin and Glucose Metabolism

May 19, 2025 updated by: Isabelle Herter-Aeberli, Swiss Federal Institute of Technology

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8092
        • Recruiting
        • Human Nutrition Laboratory ETH Zurich
        • Contact:
          • Nicole U Stoffel, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High Iron Group
15 women taking 100 mg iron twice daily for 4 days (800 mg).
Dietary supplement: 100mg iron fumarate
100mg iron fumarate b.i.d. for 4 consecutive days
Active Comparator: Low Iron Group
15 women taking 30 mg iron once daily for 14 days (420 mg).
Dietary supplement: Burgerstein Schwangerschaft & Stillzeit
contains 30 mg iron fumarate, given on 14 consecutive days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Serum hepcidin
Time Frame: before OGTT, 1 day before high/low iron supplementation
before OGTT, 1 day before high/low iron supplementation
Serum hepcidin
Time Frame: after OGTT, 1 day before high/low iron supplementation
after OGTT, 1 day before high/low iron supplementation
Serum hepcidin
Time Frame: before OGTT, after high/low iron supplementation at day 7
before OGTT, after high/low iron supplementation at day 7
Serum hepcidin
Time Frame: after OGTT, after high/low iron supplementation at day 7
after OGTT, after high/low iron supplementation at day 7
Serum iron
Time Frame: before OGTT, 1 day before high/low iron supplementation
before OGTT, 1 day before high/low iron supplementation
Serum iron
Time Frame: after OGTT, 1 day before high/low iron supplementation
after OGTT, 1 day before high/low iron supplementation
Serum iron
Time Frame: before OGTT, after high/low iron supplementation at day 7
before OGTT, after high/low iron supplementation at day 7
Serum iron
Time Frame: after OGTT, after high/low iron supplementation at day 7
after OGTT, after high/low iron supplementation at day 7
glucose
Time Frame: before OGTT, 1 day before high/low iron supplementation
before OGTT, 1 day before high/low iron supplementation
glucose
Time Frame: after OGTT, 1 day before high/low iron supplementation
after OGTT, 1 day before high/low iron supplementation
glucose
Time Frame: before OGTT, after high/low iron supplementation at day 7
before OGTT, after high/low iron supplementation at day 7
glucose
Time Frame: after OGTT, after high/low iron supplementation at day 7
after OGTT, after high/low iron supplementation at day 7
insulin
Time Frame: before OGTT, 1 day before high/low iron supplementation
before OGTT, 1 day before high/low iron supplementation
insulin
Time Frame: after OGTT, 1 day before high/low iron supplementation
after OGTT, 1 day before high/low iron supplementation
insulin
Time Frame: before OGTT, after high/low iron supplementation at day 7
before OGTT, after high/low iron supplementation at day 7
insulin
Time Frame: after OGTT, after high/low iron supplementation at day 7
after OGTT, after high/low iron supplementation at day 7
Serum hepcidin
Time Frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Serum iron
Time Frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
glucose
Time Frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
insulin
Time Frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum ferritin
Time Frame: before OGTT, 1 day before high/low iron supplementation
before OGTT, 1 day before high/low iron supplementation
Serum ferritin
Time Frame: after OGTT, 1 day before high/low iron supplementation
after OGTT, 1 day before high/low iron supplementation
Serum ferritin
Time Frame: before OGTT, after high/low iron supplementation at day 7
before OGTT, after high/low iron supplementation at day 7
Serum ferritin
Time Frame: after OGTT, after high/low iron supplementation at day 7
after OGTT, after high/low iron supplementation at day 7
soluble transferrin receptor
Time Frame: before OGTT, 1 day before high/low iron supplementation
before OGTT, 1 day before high/low iron supplementation
soluble transferrin receptor
Time Frame: after OGTT, 1 day before high/low iron supplementation
after OGTT, 1 day before high/low iron supplementation
soluble transferrin receptor
Time Frame: before OGTT, after high/low iron supplementation at day 7
before OGTT, after high/low iron supplementation at day 7
soluble transferrin receptor
Time Frame: after OGTT, after high/low iron supplementation at day 7
after OGTT, after high/low iron supplementation at day 7
c-reactive protein
Time Frame: before OGTT, 1 day before high/low iron supplementation
before OGTT, 1 day before high/low iron supplementation
c-reactive protein
Time Frame: after OGTT, 1 day before high/low iron supplementation
after OGTT, 1 day before high/low iron supplementation
c-reactive protein
Time Frame: before OGTT, after high/low iron supplementation at day 7
before OGTT, after high/low iron supplementation at day 7
c-reactive protein
Time Frame: after OGTT, after high/low iron supplementation at day 7
after OGTT, after high/low iron supplementation at day 7
alpha glycoprotein
Time Frame: before OGTT, 1 day before high/low iron supplementation
before OGTT, 1 day before high/low iron supplementation
alpha glycoprotein
Time Frame: after OGTT, 1 day before high/low iron supplementation
after OGTT, 1 day before high/low iron supplementation
alpha glycoprotein
Time Frame: before OGTT, after high/low iron supplementation at day 7
before OGTT, after high/low iron supplementation at day 7
alpha glycoprotein
Time Frame: after OGTT, after high/low iron supplementation at day 7
after OGTT, after high/low iron supplementation at day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Zürich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INDIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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