Hepcidin and Glucose Metabolism
The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Pregnancy
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2019
CompletedStudy Start
First participant enrolled
July 3, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 22, 2025
May 1, 2025
6.5 years
July 1, 2019
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (20)
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 Outcomes (16)
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
- +11 more secondary outcomes
Study Arms (2)
High Iron Group
ACTIVE COMPARATOR15 women taking 100 mg iron twice daily for 4 days (800 mg).
Low Iron Group
ACTIVE COMPARATOR15 women taking 30 mg iron once daily for 14 days (420 mg).
Interventions
100mg iron fumarate b.i.d. for 4 consecutive days
contains 30 mg iron fumarate, given on 14 consecutive days
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swiss Federal Institute of Technologylead
- University Hospital, Zürichcollaborator
Study Sites (1)
Human Nutrition Laboratory ETH Zurich
Zurich, 8092, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 5, 2019
Study Start
July 3, 2019
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share