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Effects of Maternal Folate and Folic Acid Supplementation on DNA Methylation in the Newborn Infant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02244684
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):
Young In Kim, St. Michael's Hospital, Toronto

Brief Summary:
An overwhelming body of evidence of the protective effect of folic acid supplementation on neural tube defect affected pregnancies led to mandatory folic acid fortification in Canada in 1998. Folate is an important co-factor in the transfer of one-carbon units essential in DNA synthesis, repair, and methylation reactions, aberrations of which have been implicated in the pathogenesis of several chronic diseases including cancer. Epigenetic reprogramming occurs in utero and has the potential to be modulated by the methyl donor supply of which folate is a contributor. Animal studies have shown maternal folate exposure can modulate epigenetic changes in the offspring, however, there is limited evidence of this relationship in humans. The aim of this research is to determine the effects of maternal dietary folate and supplemental folic acid intake during the periconceptional and in utero periods on global and gene-specific DNA methylation in human infants. This is a prospective observational study involving 368 Canadian mother-child pairs recruited from St. Michael's Hospital in Toronto, Ontario. Dietary and demographical information was collected from consenting pregnant women at study baseline (12-16 weeks gestation) and in the third trimester (34-37 weeks gestation). Maternal blood samples were obtained at baseline and prior to delivery and a sample of umbilical cord blood was collected at parturition to measure levels of folate status. Global and gene-specific DNA methylation in umbilical cord blood will be correlated with cord and maternal folate status. The data will be analyzed using separate ordinary least squares (OLS) regressions. Results from this study will contribute to a better understanding of how maternal folate and folic acid intake can modulate epigenetic modifications in the offspring and potentially have an effect on disease susceptibility later in life.

Condition or disease
Pregnancy Maternal Nutrition Fetal Health Epigenetics Maternal B Vitamins

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Study Type : Observational
Actual Enrollment : 368 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2010
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

Pregnant women

Primary Outcome Measures :
  1. Global CpG DNA methylation in umbilical cord blood lymphocytes determined by LC/MS-MS [ Time Frame: Day 1 ]
    Maternal dietary intake and supplemental use and blood levels of folate/folic acid and other one carbon nutrients in early and late pregnancy will be correlated with global CpG DNA methylation in umbilical cord blood lymphocytes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women were recruited from obstetrics clinics at St Michael's Hospital, a tertiary teaching hospital affiliated with the University of Toronto.

Inclusion Criteria:

  • singleton pregnancy

Exclusion Criteria:

  • celiac disease
  • Crohn's disease
  • irritable bowel disease (IBD)
  • gastric bypass surgery
  • use of antifolate medications
  • banking umbilical cord blood

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02244684

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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
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Principal Investigator: Young-In Kim, MD St. Michael's Hospital, Toronto
Principal Investigator: Deborah O'Connor, RD, PhD The Hospital for Sick Children
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Young In Kim, Senior Scientist, St. Michael's Hospital, Toronto Identifier: NCT02244684    
Other Study ID Numbers: 10-246
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Young In Kim, St. Michael's Hospital, Toronto:
Folic Acid
One-Carbon Nutrients
Fetal Health