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

NCT01264042 | Completed DMC

• 1 other identifier: NTBI_pw
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Iron Supplementation,; week 24 to 28 at study day

Outcome Measures

Primary Outcomes (1)

• NTBI

  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 Outcomes (1)

• Iron Status and History of Iron Supplements

  baseline

Study Arms (1)

FeSo4

EXPERIMENTAL

Dietary Supplement: Ferrous Sulfate

Interventions

Ferrous Sulfate DIETARY_SUPPLEMENT

60 mg with 200 mL water, single administration

Also known as: FeSO4, Dr. Paul Lohmann, Emmerthal, Germany

FeSo4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of Zurich: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

ferrous sulfate

Study Officials

• Alexander Krafft, Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 21, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

CH (1)