<?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>IRCT201306253140N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-07-05</date_registration>
      <primary_sponsor>Vice chancellor for Research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of vitamin D supplementation in the treatment of patients with gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of vitamin D supplementation on serum vitamin D levels and markers of metabolic  and  inflammatory in women with gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3179</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will receive 4 oral vitamin D supplement capsules consisting of 50000 IU of vitamin D3 ) 1 every 2 weeks for 8 weeks. Vitamin D supplements will be purchased from the Zahravi Pharm Co. All the patients will receive the supplement on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews. Intervention 2: The control group received 4 oral placebo (containing paraffin) 1 every 2 weeks for 8 weeks. Vitamin D supplements will be purchased from the Zahravi Pharm Co. All the patients will receive the supplement on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>doctor Bahram Poor Gaseme  Gargari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Street, St. Attar, School of Public Health Nutrition</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 7580</telephone>
        <email>bahrampg@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences, Faculty of Health and Nutrition</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>doctor Bahram Poor gaseme Gargari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Street, St. Attar, School of Public Health Nutrition</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 7580</telephone>
        <email>bahrampg@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: gestational diabetes; age between 15 and 45 years old and gestational age 24-28 weeks. Exclusion criteria: thyroid and parathyroid disorders, kidney disease, heart disease, hypertension, smoking and usage of nutritional supplements containing vitamin D in the past 6 months.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus in pregnancy, unspecified</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 will receive 4 oral vitamin D supplement capsules consisting of 50000 IU of vitamin D3 ) 1 every 2 weeks for 8 weeks. Vitamin D supplements will be purchased from the Zahravi Pharm Co. All the patients will receive the supplement on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews</i_keyword>
      <i_keyword>The control group received 4 oral placebo (containing paraffin) 1 every 2 weeks for 8 weeks. Vitamin D supplements will be purchased from the Zahravi Pharm Co. All the patients will receive the supplement on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum 25 (OH) vitamin D3. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: chemiluminescence immunoassay system.</prim_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic colorimetric.</prim_outcome>
      <prim_outcome>Serum Fasting insulin. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: chemiluminescence immunoassay system.</prim_outcome>
      <prim_outcome>HbA1C (Glycosilated hemoglobin). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Chromatography.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: HOMA-IR calculation.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic methods.</prim_outcome>
      <prim_outcome>Triglycerides. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic methods.</prim_outcome>
      <prim_outcome>HDL-Cholesterol. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic methods.</prim_outcome>
      <prim_outcome>High sensivity-C reactive protein. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Nephlometry.</prim_outcome>
      <prim_outcome>LDL-Cholesterol,. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Energy and macronutrients intake and vitamin D intake. Timepoint: before and after 8 weeks intervention. Method of measurement: 24-h recall Questionnaire.</sec_outcome>
      <sec_outcome>Body nass index. Timepoint: before and after 8 weeks intervention. Method of measurement: weight(Kg)/Square Height.</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>Vice chancellor for Research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-20</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golbad Street, Tabriz University of Medical Sciences Golbad Street, Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
