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

October 11, 2013 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FeSo4
Dietary supplement: Ferrous Sulfate
60 mg with 200 mL water, single administration
Other Names:
  • FeSO4, Dr. Paul Lohmann, Emmerthal, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NTBI
Time Frame: Change between baseline and 2 hours
The primary variables are NTBI values determined at baseline and two hours after the intake of 60 mg ferrous sulfate, which will allow to determine the effect of the iron supplement on NTBI formation.
Change between baseline and 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron Status and History of Iron Supplements
Time Frame: baseline
The secondary variables are iron status (Hb, ferritin, transferrin receptor) and the history of use of iron supplements. The results of NTBI measurements will be analyzed in relation to iron status and use of iron supplements.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

University of Zurich

Investigators

  • Principal Investigator: Alexander Krafft, Dr., University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (ESTIMATE)

December 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NTBI_pw

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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