Clinical trial NCT04008147: Hepcidin and Glucose Metabolism
Official title: The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Iron Deficiency Anemia of Pregnancy
Iron Metabolism Disorders
Glucose Intolerance
Gestational Diabetes
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
First posted: 2019-07-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum hepcidin
timeFrame: before OGTT, 1 day before high/low iron supplementation
measure: Serum hepcidin
timeFrame: after OGTT, 1 day before high/low iron supplementation
measure: Serum hepcidin
timeFrame: before OGTT, after high/low iron supplementation at day 7
measure: Serum hepcidin
timeFrame: after OGTT, after high/low iron supplementation at day 7
measure: Serum iron
timeFrame: before OGTT, 1 day before high/low iron supplementation
measure: Serum iron
timeFrame: after OGTT, 1 day before high/low iron supplementation
measure: Serum iron
timeFrame: before OGTT, after high/low iron supplementation at day 7
measure: Serum iron
timeFrame: after OGTT, after high/low iron supplementation at day 7
measure: glucose
timeFrame: before OGTT, 1 day before high/low iron supplementation
measure: glucose
timeFrame: after OGTT, 1 day before high/low iron supplementation
measure: glucose
timeFrame: before OGTT, after high/low iron supplementation at day 7
measure: glucose
timeFrame: after OGTT, after high/low iron supplementation at day 7
measure: insulin
timeFrame: before OGTT, 1 day before high/low iron supplementation
measure: insulin
timeFrame: after OGTT, 1 day before high/low iron supplementation
measure: insulin
timeFrame: before OGTT, after high/low iron supplementation at day 7
measure: insulin
timeFrame: after OGTT, after high/low iron supplementation at day 7
measure: Serum hepcidin
timeFrame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
measure: Serum iron
timeFrame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
measure: glucose
timeFrame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
measure: insulin
timeFrame: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Secondary outcomes:
measure: Serum ferritin
timeFrame: before OGTT, 1 day before high/low iron supplementation
measure: Serum ferritin
timeFrame: after OGTT, 1 day before high/low iron supplementation
measure: Serum ferritin
timeFrame: before OGTT, after high/low iron supplementation at day 7
measure: Serum ferritin
timeFrame: after OGTT, after high/low iron supplementation at day 7
measure: soluble transferrin receptor
timeFrame: before OGTT, 1 day before high/low iron supplementation
measure: soluble transferrin receptor
timeFrame: after OGTT, 1 day before high/low iron supplementation
measure: soluble transferrin receptor
timeFrame: before OGTT, after high/low iron supplementation at day 7
measure: soluble transferrin receptor
timeFrame: after OGTT, after high/low iron supplementation at day 7
measure: c-reactive protein
timeFrame: before OGTT, 1 day before high/low iron supplementation
measure: c-reactive protein
timeFrame: after OGTT, 1 day before high/low iron supplementation
measure: c-reactive protein
timeFrame: before OGTT, after high/low iron supplementation at day 7
measure: c-reactive protein
timeFrame: after OGTT, after high/low iron supplementation at day 7
measure: alpha glycoprotein
timeFrame: before OGTT, 1 day before high/low iron supplementation
measure: alpha glycoprotein
timeFrame: after OGTT, 1 day before high/low iron supplementation
measure: alpha glycoprotein
timeFrame: before OGTT, after high/low iron supplementation at day 7
measure: alpha glycoprotein
timeFrame: after OGTT, after high/low iron supplementation at day 7
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Human Nutrition Laboratory ETH Zurich
Study officials:
References: