Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI) (NTBI_pw)
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|ClinicalTrials.gov Identifier: NCT01264042|
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : October 14, 2013
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|
Dietary Supplement: Ferrous Sulfate
60 mg with 200 mL water, single administration
Other Name: FeSO4, Dr. Paul Lohmann, Emmerthal, Germany
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01264042
|University Hospital Zurich|
|Zurich, Switzerland, 8091|
|Principal Investigator:||Alexander Krafft, Dr.||University of Zurich|