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

NCT ID: NCT01741077

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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

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Pregnancy

Keywords

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pregnancy folic acid supplementation reproduction folate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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pregnant women

pregnant women taking 1 mg folic acid;

folic acid

Intervention Type DIETARY_SUPPLEMENT

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

non-pregnant women

non-pregnant women taking 0mg folic acid;

No interventions assigned to this group

non-pregnant women 2

non-pregnant women taking 1 mg folic acid

No interventions assigned to this group

non-pregnant women 3

non-pregnant women taking 5 mg folic acid

No interventions assigned to this group

Interventions

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folic acid

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. pregnant women-

* between 30 to 36 weeks gestation
* taking 1 mg folic acid in a multisupplement
2. non-pregnant women-

* not pregnant
* taking either 0, 1 or 5 mg folic acid in a multisupplement

Exclusion Criteria

* Taking any medications known to interfere with folate absorption at the time of sampling (ie. Antibiotics \[ can be enrolled into study if they will be off them at least two weeks prior to study commencement\], methotrexate, aminopterin)
* Those with a history of any disorders or conditions that could interfere with folate absorption or metabolism from either dietary or supplement sources such as the history/presence clinically significant gastrointestinal disease (chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved GI symptoms(diarrhea/vomiting), steatorrhea or other conditions that interfere with absorption, distribution, metabolism or excretion of folic acid.
* Those with preexisting conditions (pre-existing maternal diabetes; insulin-dependent diabetes; previous child with neural tube disorder (NTD), cleft-lip/palate or heart defect; epilepsy and/or seizure disorders) that can increase the risk of pregnancy complicated by NTD.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Brenda Hartman

Clinical Dietitian

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah L O'Connor, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Hartman BA, Fazili Z, Pfeiffer CM, O'Connor DL. Neither folic acid supplementation nor pregnancy affects the distribution of folate forms in the red blood cells of women. J Nutr. 2014 Sep;144(9):1364-9. doi: 10.3945/jn.113.189233. Epub 2014 Jul 2.

Reference Type DERIVED
PMID: 24991041 (View on PubMed)

Other Identifiers

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1000012134

Identifier Type: -

Identifier Source: org_study_id