<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/NCT02236208</url>
  </required_header>
  <id_info>
    <org_study_id>NMU-530604-XG1</org_study_id>
    <nct_id>NCT02236208</nct_id>
  </id_info>
  <brief_title>Effect of Folate Acid on Offspring Obesity</brief_title>
  <official_title>Mechanism of Folate Acid in Influencing Offspring Obesity During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to observe the effect of lack or excess of folic acid in first,&#xD;
      second and third trimester on child birth weight, fat content and the secretion of metabolism&#xD;
      related hormone, and clinical follow-up their offspring obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>May 2013</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>The level of folate acid of pregnancy women at first trimester</measure>
    <time_frame>12 weeks of pregnancy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The level of folate acid of pregnancy women at second trimester</measure>
    <time_frame>20-24 weeks of pregnancy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of folate acid of pregnancy women at third trimester</measure>
    <time_frame>28-40 weeks of pregnancy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The birth weight, fat content and metabolism related hormone secretion of their offspring</measure>
    <time_frame>At birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The weight, fat content and metabolism related hormone secretion of their offspring at one year old</measure>
    <time_frame>One years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The weight, fat content and metabolism related hormone secretion of their offspring at 3 years old</measure>
    <time_frame>3 years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The weight, fat content and metabolism related hormone secretion of their offspring at 5-7 years old</measure>
    <time_frame>5-7 years old</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The weight, fat content and the secretion of metabolism related hormone of offspring at 18 years old</measure>
    <time_frame>18 years old</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">20000</enrollment>
  <condition>Pediatric Obesity</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women with the early, mid and late pregnancy; Chilren&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy women&#xD;
&#xD;
          -  children&#xD;
&#xD;
          -  Chinese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xirong Guo, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Xirong Guo</investigator_full_name>
    <investigator_title>Vice-president of Nanjing Maternity and Child Health Care Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT02236208
org study id: NMU-530604-XG1
nct id: NCT02236208
lead sponsor: 
has dmc: Yes
The purpose of this study is to observe the effect of lack or excess of folic acid in first,
      second and third trimester on child birth weight, fat content and the secretion of metabolism
      related hormone, and clinical follow-up their offspring obesity.
observational model: Cohort
time perspective: Prospective
measure: The level of folate acid of pregnancy women at first trimester
time frame: 12 weeks of pregnancy
measure: The level of folate acid of pregnancy women at second trimester
time frame: 20-24 weeks of pregnancy
measure: The level of folate acid of pregnancy women at third trimester
time frame: 28-40 weeks of pregnancy
measure: The birth weight, fat content and metabolism related hormone secretion of their offspring
time frame: At birth
measure: The weight, fat content and metabolism related hormone secretion of their offspring at one year old
time frame: One years old
measure: The weight, fat content and metabolism related hormone secretion of their offspring at 3 years old
time frame: 3 years old
measure: The weight, fat content and metabolism related hormone secretion of their offspring at 5-7 years old
time frame: 5-7 years old
measure: The weight, fat content and the secretion of metabolism related hormone of offspring at 18 years old
time frame: 18 years old
Whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Xirong Guo, Dr.
role: Principal Investigator
affiliation: Nanjing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Xirong Guo
investigator title: Vice-president of Nanjing Maternity and Child Health Care Hospital
mesh term: Obesity
mesh term: Pediatric Obesity