<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20100408003664N25</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-23</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of vitamin D supplementation in women with hypothyroidism</public_title>
      <acronym>VITDHYPOT</acronym>
      <scientific_title>Effect of vitamin D supplementation on metabolic status, thyroid hormones, serum irisin and obesity indices in women with subclinical hypothyroidism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57482</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The eligible participants will be randomly allocated to intervention and placebo groups using a software-generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study.
In order to hide, a random sequence will not be provided to the executor and will be performed sequentially for each block, Blinding description: The placebo and supplement will be packed in the same number in similar packages. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>subclinical hypothyroidism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  50000 units weekly vitamin D of Zahravi company for 3 month. Intervention 2: Control group: Intake a Placebo perl containing sunflower oil, which is similar to vitamin D supplement in terms of dosage, color and size, once a week for 12 weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The final decision will be taken after the end of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neyshabori Avenue , Golgasht Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 83 3724 7251</telephone>
        <email>sara.safari7@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Raf raf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neyshabori Avenue , Golgasht Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 83 3724 7251</telephone>
        <email>sara.safari7@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research
Women between the ages of 20 and 65 with subclinical hypothyroidism
BMI 25-37 Kg / m2
TSH 5-10  micro units per milliliter and freeT3 and free T4 are normal</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Serum Vitamin D Levels higher than 100 μg / L
Smoking and alcohol
Pregnancy and lactation
Diabetes and infectious heart disease
Kidney failure
Cushing's syndrome
Liver diseases
Regular consumption of any dietary supplement during the last 2 months and during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other hypothyroidism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  50000 units weekly vitamin D of Zahravi company for 3 month</i_keyword>
      <i_keyword>Control group: Intake a Placebo perl containing sunflower oil, which is similar to vitamin D supplement in terms of dosage, color and size, once a week for 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum Vitamin D. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Glycemic indexes. Timepoint: Baseline and after 12 weeks after the intervention. Method of measurement: Glycemic indexes (from indicators of metabolic status) including  fasting blood sugar by enzymatic method, insulin by ELISA and insulin resistance by formula, will be measured or calculated.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Lipid profile ( from indicators of metabolic status) including total cholesterol, triglycerides and high-density lipoprotein will be measured enzymatically, and low-density lipoprotein will be calculated using the friedwald formula.</prim_outcome>
      <prim_outcome>Thyroid hormones. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Thyroid hormones including thyroid stimulating hormone, triiodothyronine and thyroxine will be measured by ELISA.</prim_outcome>
      <prim_outcome>Irisin. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Obesity indices. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Obesity indices including weight with scales and waist circumference and hip circumference will be measured with a tape measure. Body mass index will be calculated with the formula.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Body composition  will be measured by Bio impedance (BIA) method usingTanita body composition analyzer.</sec_outcome>
      <sec_outcome>Dietary intake. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: The food record questionnaire will be used to assess food intake including energy, carbohydrate, protein and fat.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: The International Physical Activity Questionnaire will be used to measure physical activity.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-10</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Science</contact_name>
        <contact_address>Tabriz University of Medical Science, Attar Neishabouri Avenue, Golgasht street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
