<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/NCT03761602</url>
  </required_header>
  <id_info>
    <org_study_id>ISCMS</org_study_id>
    <nct_id>NCT03761602</nct_id>
  </id_info>
  <brief_title>The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease</brief_title>
  <official_title>The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease: a Prospective Registry Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rongrong Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      Two hundred and ninety pregnant women with gestational age less than 20 weeks will be&#xD;
      recruited in this study. Selenium and iodine conditions, and risk of thyroid disease will be&#xD;
      monitored until termination of pregnancy, with pregnancy outcomes recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will recruit 290 pregnant women with gestational age less than 20 weeks. Iodine and&#xD;
      selenium condition will be evaluated through dietary recall (on base of Chinese food&#xD;
      ingredient information) and biochemical examinations (serum iodine concentrations, urinary&#xD;
      iodine concentrations, serum selenium concentrations, etc). The nutritional status of iodine&#xD;
      and selenium will be monitored and followed up for all the included subjects throughout the&#xD;
      pregnancy. The information of thyroid function and level of anti-TPO and anti-TG will be&#xD;
      collected. And all the complications (especially thyroid disease) in pregnancy will also be&#xD;
      recorded. All pregnant women will be followed up until the termination of pregnancy, with&#xD;
      pregnancy outcomes recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>8 Months</target_duration>
  <primary_outcome>
    <measure>risk of thyroid disease</measure>
    <time_frame>From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months</time_frame>
    <description>prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pregnancy outcomes</measure>
    <time_frame>From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months</time_frame>
    <description>prevalence of premature birth, stillbirth and abortion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prevalence of other pregnant complications</measure>
    <time_frame>From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months</time_frame>
    <description>prevalence of gestational diabetes mellitus, gestational hypertension, dyslipidemia, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prevalence of thyroid disease in neonates</measure>
    <time_frame>From date of birth to 4 weeks after birth</time_frame>
    <description>prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies，or findings of thyroid nodules) in neonates</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">290</enrollment>
  <condition>Iodine Excess in Pregnancy</condition>
  <condition>Selenium Excess in Pregnancy</condition>
  <condition>Iodine Deficiency in Pregnancy</condition>
  <condition>Selenium Deficiency in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Proper selenium and iodine condition</arm_group_label>
    <description>The subjects should have proper dietary intake of selenium and iodine, according to Chinese Dietary Reference Intakes (DRIs) (intake of selenium 65μg/d and iodine 230 μg/d).&#xD;
The Serum iodine concentration are 45-92μg/L，and the urinary I/Cr 150-249μg/g Cr.&#xD;
The Serum selenium concentrations are 18-40μg/L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Excessive selenium or iodine condition</arm_group_label>
    <description>The subjects have excessive dietary intake of selenium and iodine, usually more than 2 times of DRIs. The Serum iodine concentration are more than 100μg/L，and the urinary I/Cr more than 300μg/g Cr.&#xD;
The Serum selenium concentrations are more than 40μg/L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insufficient selenium or iodine condition</arm_group_label>
    <description>The subjects have insufficient dietary intake of either selenium or iodine, compared with DRIs. The Serum iodine concentration are less than 45μg/L，and the urinary I/Cr less than150μg/g Cr.&#xD;
The Serum selenium concentrations are less than 18μg/L.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Not applicable (for observational studies)</intervention_name>
    <description>This study is an observational study. No intervention will be administered for research purposes.</description>
    <arm_group_label>Excessive selenium or iodine condition</arm_group_label>
    <arm_group_label>Insufficient selenium or iodine condition</arm_group_label>
    <arm_group_label>Proper selenium and iodine condition</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      urine and serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Two hundred and ninety pregnant women with gestational age less than 20 weeks should be&#xD;
        recruited in this study and will be followed up throughout the whole pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical confirmation of being pregnant.&#xD;
&#xD;
          -  Being within less than 20 weeks of gestationa.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being pregnant but over 20 weeks of gestationa.&#xD;
&#xD;
          -  Mentally or psychologically unstable.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Rongrong Li</investigator_full_name>
    <investigator_title>Nutrition physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <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/NCT03761602
org study id: ISCMS
nct id: NCT03761602
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Two hundred and ninety pregnant women with gestational age less than 20 weeks will be
      recruited in this study. Selenium and iodine conditions, and risk of thyroid disease will be
      monitored until termination of pregnancy, with pregnancy outcomes recorded.
The study will recruit 290 pregnant women with gestational age less than 20 weeks. Iodine and
      selenium condition will be evaluated through dietary recall (on base of Chinese food
      ingredient information) and biochemical examinations (serum iodine concentrations, urinary
      iodine concentrations, serum selenium concentrations, etc). The nutritional status of iodine
      and selenium will be monitored and followed up for all the included subjects throughout the
      pregnancy. The information of thyroid function and level of anti-TPO and anti-TG will be
      collected. And all the complications (especially thyroid disease) in pregnancy will also be
      recorded. All pregnant women will be followed up until the termination of pregnancy, with
      pregnancy outcomes recorded.
observational model: Cohort
time perspective: Prospective
measure: risk of thyroid disease
time frame: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
description: prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies)
measure: pregnancy outcomes
time frame: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
description: prevalence of premature birth, stillbirth and abortion
measure: prevalence of other pregnant complications
time frame: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
description: prevalence of gestational diabetes mellitus, gestational hypertension, dyslipidemia, etc.
measure: prevalence of thyroid disease in neonates
time frame: From date of birth to 4 weeks after birth
description: prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies，or findings of thyroid nodules) in neonates
arm group label: Proper selenium and iodine condition
description: The subjects should have proper dietary intake of selenium and iodine, according to Chinese Dietary Reference Intakes (DRIs) (intake of selenium 65μg/d and iodine 230 μg/d).
The Serum iodine concentration are 45-92μg/L，and the urinary I/Cr 150-249μg/g Cr.
The Serum selenium concentrations are 18-40μg/L.
arm group label: Excessive selenium or iodine condition
description: The subjects have excessive dietary intake of selenium and iodine, usually more than 2 times of DRIs. The Serum iodine concentration are more than 100μg/L，and the urinary I/Cr more than 300μg/g Cr.
The Serum selenium concentrations are more than 40μg/L.
arm group label: Insufficient selenium or iodine condition
description: The subjects have insufficient dietary intake of either selenium or iodine, compared with DRIs. The Serum iodine concentration are less than 45μg/L，and the urinary I/Cr less than150μg/g Cr.
The Serum selenium concentrations are less than 18μg/L.
intervention type: Other
intervention name: Not applicable (for observational studies)
description: This study is an observational study. No intervention will be administered for research purposes.
arm group label: Excessive selenium or iodine condition
arm group label: Insufficient selenium or iodine condition
arm group label: Proper selenium and iodine condition
urine and serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Rongrong Li
investigator title: Nutrition physician
mesh term: Thyroid Diseases
sharing ipd: No