Iron Deficiency Anemia of PregnancyNCT04008147
Hepcidin and Glucose Metabolism
A study testing 100mg iron fumarate and Burgerstein Schwangerschaft & Stillzeit in people with Iron Deficiency Anemia of Pregnancy and Iron Metabolism Disorders, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders, Glucose Intolerance
- What is being tested?
- 100mg iron fumarate and Burgerstein Schwangerschaft & Stillzeit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jul 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Human Nutrition Laboratory ETH Zurich
Zurich, 8092
Nicole U Stoffel, PhD
About this study
Official title: 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.
- Conditions
- Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders, Glucose Intolerance, Gestational Diabetes
- Being tested
- 100mg iron fumarate, Burgerstein Schwangerschaft & Stillzeit
- Medical subject headings
- Iron Metabolism Disorders, Glucose Intolerance, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100mg iron fumarateDietary supplement
100mg iron fumarate b.i.d. for 4 consecutive days
Burgerstein Schwangerschaft & StillzeitDietary supplement
contains 30 mg iron fumarate, given on 14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| High Iron Group | Active comparator | 15 women taking 100 mg iron twice daily for 4 days (800 mg). Receives: Dietary Supplement: 100mg iron fumarate |
| Low Iron Group | Active comparator | 15 women taking 30 mg iron once daily for 14 days (420 mg). Receives: Dietary Supplement: Burgerstein Schwangerschaft & Stillzeit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hepcidin
Measured: before OGTT, 1 day before high/low iron supplementation
Serum hepcidin
Measured: after OGTT, 1 day before high/low iron supplementation
Serum hepcidin
Measured: before OGTT, after high/low iron supplementation at day 7
Serum hepcidin
Measured: after OGTT, after high/low iron supplementation at day 7
Serum iron
Measured: before OGTT, 1 day before high/low iron supplementation
Serum iron
Measured: after OGTT, 1 day before high/low iron supplementation
Serum iron
Measured: before OGTT, after high/low iron supplementation at day 7
Serum iron
Measured: after OGTT, after high/low iron supplementation at day 7
glucose
Measured: before OGTT, 1 day before high/low iron supplementation
glucose
Measured: after OGTT, 1 day before high/low iron supplementation
glucose
Measured: before OGTT, after high/low iron supplementation at day 7
glucose
Measured: after OGTT, after high/low iron supplementation at day 7
insulin
Measured: before OGTT, 1 day before high/low iron supplementation
insulin
Measured: after OGTT, 1 day before high/low iron supplementation
insulin
Measured: before OGTT, after high/low iron supplementation at day 7
insulin
Measured: after OGTT, after high/low iron supplementation at day 7
Serum hepcidin
Measured: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Serum iron
Measured: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
glucose
Measured: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
insulin
Measured: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Secondary outcomes (16)
Serum ferritin
Measured: before OGTT, 1 day before high/low iron supplementation
Serum ferritin
Measured: after OGTT, 1 day before high/low iron supplementation
Serum ferritin
Measured: before OGTT, after high/low iron supplementation at day 7
Serum ferritin
Measured: after OGTT, after high/low iron supplementation at day 7
soluble transferrin receptor
Measured: before OGTT, 1 day before high/low iron supplementation
soluble transferrin receptor
Measured: after OGTT, 1 day before high/low iron supplementation
soluble transferrin receptor
Measured: before OGTT, after high/low iron supplementation at day 7
soluble transferrin receptor
Measured: after OGTT, after high/low iron supplementation at day 7
c-reactive protein
Measured: before OGTT, 1 day before high/low iron supplementation
c-reactive protein
Measured: after OGTT, 1 day before high/low iron supplementation
c-reactive protein
Measured: before OGTT, after high/low iron supplementation at day 7
c-reactive protein
Measured: after OGTT, after high/low iron supplementation at day 7
alpha glycoprotein
Measured: before OGTT, 1 day before high/low iron supplementation
alpha glycoprotein
Measured: after OGTT, 1 day before high/low iron supplementation
alpha glycoprotein
Measured: before OGTT, after high/low iron supplementation at day 7
alpha glycoprotein
Measured: after OGTT, after high/low iron supplementation at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start3 Jul 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Principal investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008147
- Sponsor's protocol ID
- INDIA
- Status last verified
- May 2025
- First submitted
- 1 Jul 2019
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Pregnancy
- ClinicalTrials.gov ID
- NCT04008147
- Acronym / sponsor ID
- INDIA
- Conditions
- Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders, Glucose Intolerance, Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Iron Group | Active comparator | Dietary Supplement: 100mg iron fumarate15 women taking 100 mg iron twice daily for 4 days (800 mg). |
| Low Iron Group | Active comparator | Dietary Supplement: Burgerstein Schwangerschaft & Stillzeit15 women taking 30 mg iron once daily for 14 days (420 mg). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- week of pregnancy 24-28
- pre-pregnancy BMI <27.5kg/m2
- singleton pregnancy
- Hb > 8.0 g/dl
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100mg iron fumarate100mg iron fumarate b.i.d. for 4 consecutive days | Dietary supplement | High Iron Group |
| Burgerstein Schwangerschaft & Stillzeitcontains 30 mg iron fumarate, given on 14 consecutive days | Dietary supplement | Low Iron Group |
Primary outcome
Serum hepcidin
Time frame: before OGTT, 1 day before high/low iron supplementation
Serum hepcidin
Time frame: after OGTT, 1 day before high/low iron supplementation
Serum hepcidin
Time frame: before OGTT, after high/low iron supplementation at day 7
Serum hepcidin
Time frame: after OGTT, after high/low iron supplementation at day 7
Serum iron
Time frame: before OGTT, 1 day before high/low iron supplementation
Serum iron
Time frame: after OGTT, 1 day before high/low iron supplementation
Serum iron
Time frame: before OGTT, after high/low iron supplementation at day 7
Serum iron
Time frame: after OGTT, after high/low iron supplementation at day 7
glucose
Time frame: before OGTT, 1 day before high/low iron supplementation
glucose
Time frame: after OGTT, 1 day before high/low iron supplementation
glucose
Time frame: before OGTT, after high/low iron supplementation at day 7
glucose
Time frame: after OGTT, after high/low iron supplementation at day 7
insulin
Time frame: before OGTT, 1 day before high/low iron supplementation
insulin
Time frame: after OGTT, 1 day before high/low iron supplementation
insulin
Time frame: before OGTT, after high/low iron supplementation at day 7
insulin
Time frame: 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
Serum iron
Time frame: 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
insulin
Time frame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
16 secondary outcomes
Serum ferritin
Time frame: before OGTT, 1 day before high/low iron supplementation
Serum ferritin
Time frame: after OGTT, 1 day before high/low iron supplementation
Serum ferritin
Time frame: before OGTT, after high/low iron supplementation at day 7
Serum ferritin
Time frame: after OGTT, after high/low iron supplementation at day 7
soluble transferrin receptor
Time frame: before OGTT, 1 day before high/low iron supplementation
soluble transferrin receptor
Time frame: after OGTT, 1 day before high/low iron supplementation
soluble transferrin receptor
Time frame: 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
c-reactive protein
Time frame: before OGTT, 1 day before high/low iron supplementation
c-reactive protein
Time frame: after OGTT, 1 day before high/low iron supplementation
c-reactive protein
Time frame: 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
alpha glycoprotein
Time frame: before OGTT, 1 day before high/low iron supplementation
alpha glycoprotein
Time frame: after OGTT, 1 day before high/low iron supplementation
alpha glycoprotein
Time frame: before OGTT, after high/low iron supplementation at day 7
alpha glycoprotein
Time frame: after OGTT, after high/low iron supplementation at day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency Anemia of Pregnancy
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
RecruitingObservational study
Maternal Iron Deficiency and Childhood Health
Iron Deficiency Anaemia in Childbirth, Iron Deficiency
Not yet recruiting
Menstruation and Anemia Research: A Community Health Study
Anemia
RecruitingPhase 3
Ferric Citrate in Iron Deficiency Anemia During Pregnancy
Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100mg iron fumarate and Burgerstein Schwangerschaft & Stillzeit in people with Iron Deficiency Anemia of Pregnancy and Iron Metabolism Disorders, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole U Stoffel, PhD (+41 44 632 83 93, nicole.stoffel@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum hepcidin (time frame: before OGTT, 1 day before high/low iron supplementation). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.