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

Pregnancy Clinical Trial

— NTBI_pw  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264042
• Other study ID #: NTBI_pw
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: October 11, 2013
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• Ferrous Sulfate
60 mg with 200 mL water, single administration

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No