Hepcidin and Glucose Metabolism

Not Applicable

Recruiting

• Conditions: Iron Deficiency Anemia of Pregnancy; Iron Metabolism Disorders; Gestational Diabetes; Glucose Intolerance
• Interventions: Dietary Supplement: 100mg iron fumarate; Dietary Supplement: Burgerstein Schwangerschaft & Stillzeit

• Registration Number: NCT04008147
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study Start: 2019-07-03
• Study First Posted: 2019-07-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Iron Group	100mg iron fumarate	15 women taking 100 mg iron twice daily for 4 days (800 mg).
Low Iron Group	Burgerstein Schwangerschaft & Stillzeit	15 women taking 30 mg iron once daily for 14 days (420 mg).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
alpha glycoprotein	after OGTT, after high/low iron supplementation at day 7
Serum ferritin	after OGTT, after high/low iron supplementation at day 7
c-reactive protein	after OGTT, after high/low iron supplementation at day 7
soluble transferrin receptor	after OGTT, after high/low iron supplementation at day 7

Trial Locations

Locations (1)

Human Nutrition Laboratory ETH Zurich; 🇨🇭 Zürich, Switzerland