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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Dietary Supplement: Ferrous Sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FeSo4<br> | Dietary Supplement: Ferrous Sulfate<br>* 60 mg with 200 mL water, single administration<br>* Other names: FeSO4, Dr. Paul Lohmann, Emmerthal, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NTBI | 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. | Change between baseline and 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron Status and History of Iron Supplements | 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. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron Supplementation,, week 24 to 28 at study day