<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/NCT02236221</url>
  </required_header>
  <id_info>
    <org_study_id>NMU-530604-XG2</org_study_id>
    <nct_id>NCT02236221</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D on Offspring Obesity</brief_title>
  <official_title>Mechanism of Vitamin D 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 Vitamin D in the&#xD;
      first, second and third trimester on child birth weight, fat content and the secretion of&#xD;
      metabolism 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 Vitamin D of pregnancy women at second trimester</measure>
    <time_frame>20-24 weeks of pregnancy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The level of Vitamin D of pregnancy women at first trimester</measure>
    <time_frame>12 weeks of pregnancy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of Vitamin D 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">30000</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>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>
  <pending_results>
    <submitted>April 1, 2017</submitted>
    <returned>June 15, 2017</returned>
  </pending_results>
  <!-- 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/NCT02236221
org study id: NMU-530604-XG2
nct id: NCT02236221
lead sponsor: 
has dmc: Yes
The purpose of this study is to observe the effect of lack or excess of Vitamin D in the
      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 Vitamin D of pregnancy women at second trimester
time frame: 20-24 weeks of pregnancy
measure: The level of Vitamin D of pregnancy women at first trimester
time frame: 12 weeks of pregnancy
measure: The level of Vitamin D 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: 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
submitted: April 1, 2017
returned: June 15, 2017