<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/NCT03279315</url>
  </required_header>
  <id_info>
    <org_study_id>NSFC-31340033</org_study_id>
    <nct_id>NCT03279315</nct_id>
  </id_info>
  <brief_title>An Iodine Balance Experiment</brief_title>
  <official_title>Exploration of the Appropriate Recommended Nutrient Intake of Iodine in Chinese Euthyroid Women: an Iodine Balance Experiment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University</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>
      A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different&#xD;
      iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different&#xD;
      periods. The total iodine intake from diet, water and air as well as the total iodine&#xD;
      excretion by urine, faces and respiration were monitored and determined, and a total of 300&#xD;
      samples were collected. The sweat iodine loss was also considered. Moreover, the regression&#xD;
      curve model between the 24-h iodine intake and 24-h iodine excretion was also established.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The experiment was conducted between November and December with a total duration of 1 month.&#xD;
      Referring to the experience from Harrison and Dworkin, however, considering the negative&#xD;
      iodine balance reported, during the first 3 weeks, the diet was provided with non-iodized&#xD;
      salt, while the diet with iodized salt was only offered in the last week. The total daily&#xD;
      iodine intake consisted of dietary iodine intake, water iodine intake and iodine from&#xD;
      breathing, while iodine could be excreted out of human body by urine, faces, sweat and&#xD;
      breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each&#xD;
      individual participant, and the iodine balance was calculated accordingly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2014</start_date>
  <completion_date type="Actual">March 10, 2017</completion_date>
  <primary_completion_date type="Actual">December 19, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants received a diet with iodized table salt or non-iodized table salt</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total iodine intake and total iodine excretion</measure>
    <time_frame>12 days</time_frame>
    <description>Iodine intake includes iodine from food, water and air (μg/d).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total iodine excretion</measure>
    <time_frame>12 days</time_frame>
    <description>Iodine excretion includes iodine excreted by urine, feces, sweat and breath (μg/d).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urinary iodine concentration (UIC)</measure>
    <time_frame>At the beginning of the experiment</time_frame>
    <description>μg/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thyroid function</measure>
    <time_frame>At the beginning of the experiment</time_frame>
    <description>FT3 (pmol/L), FT4 (pmol/L),TSH (mIU/L), TG (ng/mL), TGAb (IU/mL), TPOAb (IU/mL)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Iodine Deficiency</condition>
  <condition>Nutritional Requirements</condition>
  <arm_group>
    <arm_group_label>experimental period</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the first period was with non-iodized salt, the second period was with iodized salt.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>iodized table salt, non-iodized table salt</intervention_name>
    <description>During the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week.</description>
    <arm_group_label>experimental period</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The ones with normal thyroid function, urinary iodine concentration, agree with the&#xD;
             experiment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The ones with abnormal thyroid hormone level, urinary iodine concentration (UIC) or&#xD;
             autoantibody-positive were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin Medical University</investigator_affiliation>
    <investigator_full_name>Wanqi Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Iodine</keyword>
  <keyword>Balance experiment</keyword>
  <keyword>EAR</keyword>
  <keyword>Chinese women</keyword>
  <keyword>Euthyroid</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/NCT03279315
org study id: NSFC-31340033
nct id: NCT03279315
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different
      iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different
      periods. The total iodine intake from diet, water and air as well as the total iodine
      excretion by urine, faces and respiration were monitored and determined, and a total of 300
      samples were collected. The sweat iodine loss was also considered. Moreover, the regression
      curve model between the 24-h iodine intake and 24-h iodine excretion was also established.
The experiment was conducted between November and December with a total duration of 1 month.
      Referring to the experience from Harrison and Dworkin, however, considering the negative
      iodine balance reported, during the first 3 weeks, the diet was provided with non-iodized
      salt, while the diet with iodized salt was only offered in the last week. The total daily
      iodine intake consisted of dietary iodine intake, water iodine intake and iodine from
      breathing, while iodine could be excreted out of human body by urine, faces, sweat and
      breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each
      individual participant, and the iodine balance was calculated accordingly.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants received a diet with iodized table salt or non-iodized table salt
primary purpose: Basic Science
masking: None (Open Label)
measure: Total iodine intake and total iodine excretion
time frame: 12 days
description: Iodine intake includes iodine from food, water and air (μg/d).
measure: Total iodine excretion
time frame: 12 days
description: Iodine excretion includes iodine excreted by urine, feces, sweat and breath (μg/d).
measure: urinary iodine concentration (UIC)
time frame: At the beginning of the experiment
description: μg/L
measure: Thyroid function
time frame: At the beginning of the experiment
description: FT3 (pmol/L), FT4 (pmol/L),TSH (mIU/L), TG (ng/mL), TGAb (IU/mL), TPOAb (IU/mL)
arm group label: experimental period
arm group type: Experimental
description: the first period was with non-iodized salt, the second period was with iodized salt.
intervention type: Dietary Supplement
intervention name: iodized table salt, non-iodized table salt
description: During the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week.
arm group label: experimental period
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Tianjin Medical University
investigator full name: Wanqi Zhang
investigator title: Professor
sharing ipd: No