Hepcidin and Glucose Metabolism

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: Recruiting
• Conditions: Iron Metabolism Disorders; Glucose Intolerance; Gestational Diabetes; Iron Deficiency Anemia of Pregnancy
• Intervention / Treatment: Dietary supplement: 100mg iron fumarate; Dietary supplement: Burgerstein Schwangerschaft & Stillzeit

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole U Stoffel, PhD; Phone Number: +41 44 632 83 93; Email: nicole.stoffel@hest.ethz.ch

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Serum hepcidin	before OGTT, 1 day before high/low iron supplementation
Serum hepcidin	after OGTT, 1 day before high/low iron supplementation
Serum hepcidin	before OGTT, after high/low iron supplementation at day 7
Serum hepcidin	after OGTT, after high/low iron supplementation at day 7
Serum iron	before OGTT, 1 day before high/low iron supplementation
Serum iron	after OGTT, 1 day before high/low iron supplementation
Serum iron	before OGTT, after high/low iron supplementation at day 7
Serum iron	after OGTT, after high/low iron supplementation at day 7
glucose	before OGTT, 1 day before high/low iron supplementation
glucose	after OGTT, 1 day before high/low iron supplementation
glucose	before OGTT, after high/low iron supplementation at day 7
glucose	after OGTT, after high/low iron supplementation at day 7
insulin	before OGTT, 1 day before high/low iron supplementation
insulin	after OGTT, 1 day before high/low iron supplementation
insulin	before OGTT, after high/low iron supplementation at day 7
insulin	after OGTT, after high/low iron supplementation at day 7
Serum hepcidin	At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Serum iron	At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
glucose	At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
insulin	At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum ferritin	before OGTT, 1 day before high/low iron supplementation
Serum ferritin	after OGTT, 1 day before high/low iron supplementation
Serum ferritin	before OGTT, after high/low iron supplementation at day 7
Serum ferritin	after OGTT, after high/low iron supplementation at day 7
soluble transferrin receptor	before OGTT, 1 day before high/low iron supplementation
soluble transferrin receptor	after OGTT, 1 day before high/low iron supplementation
soluble transferrin receptor	before OGTT, after high/low iron supplementation at day 7
soluble transferrin receptor	after OGTT, after high/low iron supplementation at day 7
c-reactive protein	before OGTT, 1 day before high/low iron supplementation
c-reactive protein	after OGTT, 1 day before high/low iron supplementation
c-reactive protein	before OGTT, after high/low iron supplementation at day 7
c-reactive protein	after OGTT, after high/low iron supplementation at day 7
alpha glycoprotein	before OGTT, 1 day before high/low iron supplementation
alpha glycoprotein	after OGTT, 1 day before high/low iron supplementation
alpha glycoprotein	before OGTT, after high/low iron supplementation at day 7
alpha glycoprotein	after OGTT, after high/low iron supplementation at day 7

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: University Hospital, Zürich

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Hematologic Diseases; Anemia; Anemia, Hypochromic; Hyperglycemia; Iron Deficiencies; Diabetes, Gestational; Anemia, Iron-Deficiency; Metabolic Diseases; Glucose Intolerance; Iron Metabolism Disorders
• Other Study ID 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