<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02244684</url>
  </required_header>
  <id_info>
    <org_study_id>10-246</org_study_id>
    <nct_id>NCT02244684</nct_id>
  </id_info>
  <brief_title>Effects of Maternal Folate and Folic Acid Supplementation on DNA Methylation in the Newborn Infant</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <brief_summary>
    <textblock>
      An overwhelming body of evidence of the protective effect of folic acid supplementation on&#xD;
      neural tube defect affected pregnancies led to mandatory folic acid fortification in Canada&#xD;
      in 1998. Folate is an important co-factor in the transfer of one-carbon units essential in&#xD;
      DNA synthesis, repair, and methylation reactions, aberrations of which have been implicated&#xD;
      in the pathogenesis of several chronic diseases including cancer. Epigenetic reprogramming&#xD;
      occurs in utero and has the potential to be modulated by the methyl donor supply of which&#xD;
      folate is a contributor. Animal studies have shown maternal folate exposure can modulate&#xD;
      epigenetic changes in the offspring, however, there is limited evidence of this relationship&#xD;
      in humans. The aim of this research is to determine the effects of maternal dietary folate&#xD;
      and supplemental folic acid intake during the periconceptional and in utero periods on global&#xD;
      and gene-specific DNA methylation in human infants. This is a prospective observational study&#xD;
      involving 368 Canadian mother-child pairs recruited from St. Michael's Hospital in Toronto,&#xD;
      Ontario. Dietary and demographical information was collected from consenting pregnant women&#xD;
      at study baseline (12-16 weeks gestation) and in the third trimester (34-37 weeks gestation).&#xD;
      Maternal blood samples were obtained at baseline and prior to delivery and a sample of&#xD;
      umbilical cord blood was collected at parturition to measure levels of folate status. Global&#xD;
      and gene-specific DNA methylation in umbilical cord blood will be correlated with cord and&#xD;
      maternal folate status. The data will be analyzed using separate ordinary least squares (OLS)&#xD;
      regressions. Results from this study will contribute to a better understanding of how&#xD;
      maternal folate and folic acid intake can modulate epigenetic modifications in the offspring&#xD;
      and potentially have an effect on disease susceptibility later in life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Global CpG DNA methylation in umbilical cord blood lymphocytes determined by LC/MS-MS</measure>
    <time_frame>Day 1</time_frame>
    <description>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</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">368</enrollment>
  <condition>Pregnancy</condition>
  <condition>Maternal Nutrition</condition>
  <condition>Fetal Health</condition>
  <condition>Epigenetics</condition>
  <condition>Maternal B Vitamins</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women were recruited from obstetrics clinics at St Michael's Hospital, a tertiary&#xD;
        teaching hospital affiliated with the University of Toronto.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  celiac disease&#xD;
&#xD;
          -  Crohn's disease&#xD;
&#xD;
          -  irritable bowel disease (IBD)&#xD;
&#xD;
          -  gastric bypass surgery&#xD;
&#xD;
          -  use of antifolate medications&#xD;
&#xD;
          -  banking umbilical cord blood&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-In Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Deborah O'Connor, RD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Unity Health Toronto</investigator_affiliation>
    <investigator_full_name>Young In Kim</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>Folate</keyword>
  <keyword>Folic Acid</keyword>
  <keyword>One-Carbon Nutrients</keyword>
  <keyword>Epigenetics</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Fetal Health</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02244684
org study id: 10-246
nct id: NCT02244684
lead sponsor: 
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.
observational model: Cohort
time perspective: Prospective
measure: Global CpG DNA methylation in umbilical cord blood lymphocytes determined by LC/MS-MS
time frame: Day 1
description: 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
arm group label: Pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Young-In Kim, MD
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Deborah O'Connor, RD, PhD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Unity Health Toronto
investigator full name: Young In Kim
investigator title: Senior Scientist