Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI) (NTBI_pw)
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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) |
- NTBI [ Time Frame: March 2012 ] [ 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: March 2012 ] [ 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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 |
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| Contact: Alexander Krafft, Dr. med. | 0041442551111 | alexander.krafft@usz.ch |
| Contact: Ines Egli, Dr. sc. nat. | ines.egli@ilw.agrl.ethz.ch |
| Switzerland | |
| University Hospital Zurich | Recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Alexander Krafft Alexander.Krafft@usz.ch | |
| Principal Investigator: Alexander Krafft | |
| 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: | November 9, 2012 |
| 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 May 21, 2013