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OpenTrials
Completed

NCT Number: NCT01264042

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Sulfate

Dietary Supplement

60 mg with 200 mL water, single administration

Other names: FeSO4, Dr. Paul Lohmann, Emmerthal, Germany

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • University of Zurich

Registry information

Acronym: NTBI_pw

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2010
Registry last updated
Oct 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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