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Trials / Completed

CompletedNCT01741077

The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells

Status
Completed
Phase
Study type
Observational
Enrollment
32 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
Female
Age
20 Years – 35 Years
Healthy volunteers
Accepted

Summary

The purpose of this cross-sectional study was to examine whether or not physical changes or adaptations occur in response pregnancy or to the higher intakes of folic acid from supplementation typically consumed during the reproductive period.

Detailed description

Higher folate requirements during pregnancy to support growth and development are well established but it is unknown what metabolic changes occur in 1-carbon metabolism to provide sufficient nucleotides for DNA/RNA synthesis. Periconceptual folic acid (FA) supplementation and fortification of the food supply have been shown to reduce the risk of pregnancies with neural tube defects but conversely expose women to high FA intakes for extended periods of time. The purpose of this cross-sectional study is to establish if physiological adaptations occur in folate metabolism in response to pregnancy or higher intakes of FA typically consumed among women during the reproductive period. A convenience sample of thirty-two women (n=8/group) were recruited to compare the total concentrations and forms of folate (tetrahydrofolate \[THF\], 5-methylTHF, 5-formylTHF and 5, 10-methenylTHF) in red blood cells in four groups: a) pregnant women (PW, 30-36 weeks gestation) taking 1.0 mg of FA b) non-pregnant women (NPW) taking 0 mg of FA c) NPW taking 1.0 mg FA and d) NPW taking 5.0 mg FA. Blood samples were taken at a single time point and compared across groups. Total red blood cell concentrations were measured using both microbiological assay and liquid chromatography/tandem mass spectrometry (LC/MS/MS) analysis. LC/MS/MS analysis was used to determine folate form concentrations.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTfolic acidsubjects take multivitamin supplement containing folic acid. Women were enrolled based on whether or not they were taking supplements.

Timeline

Start date
2008-05-01
Primary completion
2008-10-01
Completion
2010-04-01
First posted
2012-12-04
Last updated
2013-12-05

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01741077. Inclusion in this directory is not an endorsement.

The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells (NCT01741077) · Clinical Trials Directory