<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/NCT03305900</url>
  </required_header>
  <id_info>
    <org_study_id>12.190 HREA</org_study_id>
    <nct_id>NCT03305900</nct_id>
  </id_info>
  <brief_title>Determinants of Formate Concentrations</brief_title>
  <official_title>Lifestyle, Metabolite and Genetic Determinants of Formate Concentrations in a Cross-sectional Study of Young, Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial University of Newfoundland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Dublin, Trinity College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial University of Newfoundland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Formate is an important metabolite, serving as a donor of one-carbon groups to the&#xD;
      intracellular tetrahydrofolate pool. However, little is known of its circulating&#xD;
      concentrations or of their determinants. This study seeks to define formate levels and their&#xD;
      determinants in a young, healthy population.&#xD;
&#xD;
      Serum formate will be measured in 1701 subjects from the Trinity Student Study. The subjects,&#xD;
      males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin. Formate&#xD;
      levels will be compared with other one-carbon metabolites, vitamin status, potential formate&#xD;
      precursors, genetic polymorphisms, and lifestyle factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2012</start_date>
  <completion_date type="Actual">November 26, 2013</completion_date>
  <primary_completion_date type="Actual">November 26, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Formate concentrations</measure>
    <time_frame>Single baseline measurement; cross sectional, observational study</time_frame>
    <description>Formate concentrations in study population</description>
  </primary_outcome>
  <enrollment type="Actual">1701</enrollment>
  <condition>Healthy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>Cross-sectional study requiring a single serum sample</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Serum formate was measured in 1701 subjects from the Trinity Student Study. The subjects,&#xD;
        males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Trinity College Dublin students with Irish grandparents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>28 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Molloy, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>University of Dublin, Trinity College</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Memorial University of Newfoundland</investigator_affiliation>
    <investigator_full_name>John (Sean) Brosnan</investigator_full_name>
    <investigator_title>Professor of Biochemistry</investigator_title>
  </responsible_party>
  <keyword>formate</keyword>
  <keyword>one-carbon metabolism</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03305900
org study id: 12.190 HREA
nct id: NCT03305900
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Formate is an important metabolite, serving as a donor of one-carbon groups to the
      intracellular tetrahydrofolate pool. However, little is known of its circulating
      concentrations or of their determinants. This study seeks to define formate levels and their
      determinants in a young, healthy population.

      Serum formate will be measured in 1701 subjects from the Trinity Student Study. The subjects,
      males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin. Formate
      levels will be compared with other one-carbon metabolites, vitamin status, potential formate
      precursors, genetic polymorphisms, and lifestyle factors.
observational model: Cohort
time perspective: Cross-Sectional
measure: Formate concentrations
time frame: Single baseline measurement; cross sectional, observational study
description: Formate concentrations in study population
intervention type: Other
intervention name: No Intervention
description: Cross-sectional study requiring a single serum sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 28 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Molloy, Ph.D.
role: Study Chair
affiliation: University of Dublin, Trinity College
responsible party type: Principal Investigator
investigator affiliation: Memorial University of Newfoundland
investigator full name: John (Sean) Brosnan
investigator title: Professor of Biochemistry
sharing ipd: No