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Recruiting NCT04008147

Hepcidin and Glucose Metabolism

No phase Interventional Iron Deficiency Anemia of Pregnancy Iron Metabolism Disorders Glucose Intolerance Gestational Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 100mg iron fumarate, Burgerstein Schwangerschaft & Stillzeit.
Who it may be relevant to
Registry conditions: Iron Deficiency Anemia of Pregnancy, Iron Metabolism Disorders, Glucose Intolerance, Gestational Diabetes. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Pregnancy

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Switzerland · 1 center
  • Human Nutrition Laboratory ETH Zurich — Zurich

Identifiers

NCT: NCT04008147 · INDIA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗