Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI) (NTBI_pw)
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.
|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)|
- 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.
- 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.
|Study Start Date:||January 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Dietary Supplement: Ferrous Sulfate
60 mg with 200 mL water, single administration
Other Name: FeSO4, Dr. Paul Lohmann, Emmerthal, Germany
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264042
|University Hospital Zurich|
|Zurich, Switzerland, 8091|
|Principal Investigator:||Alexander Krafft, Dr.||University of Zurich|