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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04008147
Other study ID # INDIA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 3, 2019
Est. completion date December 31, 2023

Study information

Verified date October 2023
Source Swiss Federal Institute of Technology
Contact Nicole U Stoffel, PhD
Phone +41 44 632 83 93
Email nicole.stoffel@hest.ethz.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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


Intervention

Dietary Supplement:
100mg iron fumarate
100mg iron fumarate b.i.d. for 4 consecutive days
Burgerstein Schwangerschaft & Stillzeit
contains 30 mg iron fumarate, given on 14 consecutive days

Locations

Country Name City State
Switzerland Human Nutrition Laboratory ETH Zurich Zürich

Sponsors (2)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum hepcidin before OGTT, 1 day before high/low iron supplementation
Primary Serum hepcidin after OGTT, 1 day before high/low iron supplementation
Primary Serum hepcidin before OGTT, after high/low iron supplementation at day 7
Primary Serum hepcidin after OGTT, after high/low iron supplementation at day 7
Primary Serum iron before OGTT, 1 day before high/low iron supplementation
Primary Serum iron after OGTT, 1 day before high/low iron supplementation
Primary Serum iron before OGTT, after high/low iron supplementation at day 7
Primary Serum iron after OGTT, after high/low iron supplementation at day 7
Primary glucose before OGTT, 1 day before high/low iron supplementation
Primary glucose after OGTT, 1 day before high/low iron supplementation
Primary glucose before OGTT, after high/low iron supplementation at day 7
Primary glucose after OGTT, after high/low iron supplementation at day 7
Primary insulin before OGTT, 1 day before high/low iron supplementation
Primary insulin after OGTT, 1 day before high/low iron supplementation
Primary insulin before OGTT, after high/low iron supplementation at day 7
Primary insulin after OGTT, after high/low iron supplementation at day 7
Primary Serum hepcidin At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Primary Serum iron At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Primary glucose At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Primary insulin At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Secondary Serum ferritin before OGTT, 1 day before high/low iron supplementation
Secondary Serum ferritin after OGTT, 1 day before high/low iron supplementation
Secondary Serum ferritin before OGTT, after high/low iron supplementation at day 7
Secondary Serum ferritin after OGTT, after high/low iron supplementation at day 7
Secondary soluble transferrin receptor before OGTT, 1 day before high/low iron supplementation
Secondary soluble transferrin receptor after OGTT, 1 day before high/low iron supplementation
Secondary soluble transferrin receptor before OGTT, after high/low iron supplementation at day 7
Secondary soluble transferrin receptor after OGTT, after high/low iron supplementation at day 7
Secondary c-reactive protein before OGTT, 1 day before high/low iron supplementation
Secondary c-reactive protein after OGTT, 1 day before high/low iron supplementation
Secondary c-reactive protein before OGTT, after high/low iron supplementation at day 7
Secondary c-reactive protein after OGTT, after high/low iron supplementation at day 7
Secondary alpha glycoprotein before OGTT, 1 day before high/low iron supplementation
Secondary alpha glycoprotein after OGTT, 1 day before high/low iron supplementation
Secondary alpha glycoprotein before OGTT, after high/low iron supplementation at day 7
Secondary alpha glycoprotein after OGTT, after high/low iron supplementation at day 7
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