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Trial record 2 of 211 for:    folic acid AND pregnancy NOT (male OR men)

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

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ClinicalTrials.gov Identifier: NCT01741077
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 5, 2013
Sponsor:
Information provided by (Responsible Party):
Brenda Hartman, The Hospital for Sick Children

November 27, 2012
December 4, 2012
December 5, 2013
May 2008
October 2008   (Final data collection date for primary outcome measure)
Red blood cell folate concentrations - tetrahydrofolate (THF) [ Time Frame: At the point of participation (this is a single visit, single test study) ]
Bood samples were taken once at the point of participation and compared 1) pregnant women (between 30-36 weeks gestation) and non-pregnant women who were taking supplements 2) 0 mg folic acid 3) 1 mg FA, 4) and 5 mg FA. Those who were taking supplements were taking them for a minimum of 30 weeks.
Red blood cell folate form concentrations [ Time Frame: At the point of participation (this is a single visit, single test study) ]
Bood samples were taken once at the point of participation and compared 1) pregnant women (between 30-36 weeks gestation) and non-pregnant women who were taking supplements 2) 0 mg folic acid 3) 1 mg FA, 4) and 5 mg FA. Those who were taking supplements were taking them for a minimum of 30 weeks.
Complete list of historical versions of study NCT01741077 on ClinicalTrials.gov Archive Site
  • Red blood cell folate concentrations - 5-methyltetrahydrofolate (5-methylTHF) [ Time Frame: At the point of participation (this is a single visit, single test study) ]
  • Red blood cell concentrations - 5-formyltetrahydrofolate (5-formylTHF) [ Time Frame: At the point of participation (this is a single visit, single test study) ]
  • Red blood cell folate concentrations - 5,10-Methenyltetrahydrofolate (5,10-methenylTHF) [ Time Frame: At the point of participation (this is a single visit, single test study) ]
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The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells
The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
women of reproductive age
Pregnancy
Dietary Supplement: folic acid
subjects take multivitamin supplement containing folic acid. Women were enrolled based on whether or not they were taking supplements.
  • pregnant women
    pregnant women taking 1 mg folic acid;
    Intervention: Dietary Supplement: folic acid
  • non-pregnant women
    non-pregnant women taking 0mg folic acid;
  • non-pregnant women 2
    non-pregnant women taking 1 mg folic acid
  • non-pregnant women 3
    non-pregnant women taking 5 mg folic acid
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Same as current
April 2010
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
20 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01741077
1000012134
No
Not Provided
Not Provided
Brenda Hartman, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Deborah L O'Connor, PhD The Hospital for Sick Children
The Hospital for Sick Children
December 2013