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

This study has been completed.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01264042
First received: December 20, 2010
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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 Intervention
Pregnancy
Dietary Supplement: Ferrous Sulfate

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI)

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • NTBI [ Time Frame: Change between baseline and 2 hours ] [ Designated as safety issue: No ]
    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:
  • Iron Status and History of Iron Supplements [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FeSo4 Dietary Supplement: Ferrous Sulfate
60 mg with 200 mL water, single administration
Other Name: FeSO4, Dr. Paul Lohmann, Emmerthal, Germany

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01264042

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

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01264042     History of Changes
Other Study ID Numbers: NTBI_pw
Study First Received: December 20, 2010
Last Updated: October 11, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Federal Institute of Technology:
Iron Supplementation,
week 24 to 28 at study day

Additional relevant MeSH terms:
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014