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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01264042
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : October 14, 2013
University of Zurich
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Ferrous Sulfate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI)
Study Start Date : January 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FeSo4 Dietary Supplement: Ferrous Sulfate
60 mg with 200 mL water, single administration
Other Name: FeSO4, Dr. Paul Lohmann, Emmerthal, Germany

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01264042

University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
Swiss Federal Institute of Technology
University of Zurich
Principal Investigator: Alexander Krafft, Dr. University of Zurich

Responsible Party: Prof. Michael B. Zimmermann, Prof., Swiss Federal Institute of Technology Identifier: NCT01264042     History of Changes
Other Study ID Numbers: NTBI_pw
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

Keywords provided by Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology:
Iron Supplementation,
week 24 to 28 at study day