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Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI)

NCT ID: NCT01264042

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-09-30

Brief Summary

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Although the essential role of iron during pregnancy is well established, concerns have been raised that current iron supplements given routinely during pregnancy may also have harmful consequences, such as increased oxidative stress and enhanced risks of infection, pre-eclampsia and impaired glucose regulation. A potential mechanism for the production of adverse effects is the appearance of non-transferrin-bound iron after oral administration of iron supplements. Non-transferrin-bound iron is more readily available to pathogens and could promote injurious free radical reactions that might add to the oxidative stress of pregnancy.

The present study will determine if oral administration of 60 mg of iron as ferrous sulfate during the second trimester of pregnancy is followed by the appearance of non-transferrin-bound iron two hours later. The investigators will examine the influence of a variety of factors, including iron status and previous use of iron supplements. Detection of non-transferrin-bound iron after administration of an iron supplement to pregnant women would be an important new observation that could lead to re-evaluation of current methods of iron supplementation.

Detailed Description

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Conditions

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Pregnancy

Keywords

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Iron Supplementation, week 24 to 28 at study day

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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FeSo4

Group Type EXPERIMENTAL

Ferrous Sulfate

Intervention Type DIETARY_SUPPLEMENT

60 mg with 200 mL water, single administration

Interventions

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Ferrous Sulfate

60 mg with 200 mL water, single administration

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FeSO4, Dr. Paul Lohmann, Emmerthal, Germany

Eligibility Criteria

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Inclusion Criteria

* Pregnant woman
* Age 18 to 45 years
* singleton pregnancy
* between 24 and 28 of gestation (at study day)
* regular visits at prenatal clinic
* capability and willingness to comply with study protocol
* voluntary signed informed consent

Exclusion Criteria

* Multiple pregnancy
* Acute or chronic disease or disorder
* Incapability of following the study protocol
* Homelessness
* Active drug/alcohol dependence or abuse history
* Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Krafft, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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NTBI_pw

Identifier Type: -

Identifier Source: org_study_id