<?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>IRCT2016101030248N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-17</date_registration>
      <primary_sponsor>Vice chancellor for research, Urmia  University of Medical Sciences</primary_sponsor>
      <public_title>Assessment of vitamin D oral supplementationon on insulin resistance, visceral fat and adiponectin in women with polycystic ovary syndrome and hypovitaminosis D</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of  vitamin D oral supplementation  on insulin resistance, visceral fat and adiponectin in women with polycystic ovary syndrome and hypovitaminosis D</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24098</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In order to avoid the possible effect of awareness of allocation to treatment or placebo groups a single blind design was used which only researcher was awareness of randomizing into two groups. According to the number's of randomized table, we put patient into two groups and they did not know any things about this.</study_design>
      <phase>2</phase>
      <hc_freetext>Polycystic Ovary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention: 8 vitamin D3 capsule 50000 IU during 2 month (1 capsule in the week after lunch). Intervention 2: Control: 8 placebo capsule(Paraffinedible) during 2 month (1 capsule in the week after lunch).</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>Dr.Sakineh Nouri Saeidlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran (Postal Code:571478334)</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3276 6825</telephone>
        <email>saeedlou2003@yahoo.com; nourisaeidlou_s@umsu.ac.ir</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sakineh Nouri Saeedlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University of Medical Sciences ,Health Research Center Food &amp; Beverage</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 44 3276 6825</telephone>
        <email>saeedlou2003@yahoo.com; nourisaeidlou_s@umsu.ac.ir</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Women with pcos according rotterdom criteria; Vitamin D deficiency ( x=&lt;20 ng); OCPs consumer; Age between 20 to 38&#13;
Exclude  criteria: Under 20 and over 38 years old; Neoplastic disorders; hepatic; renal; cardiovascular; malabsorptive and pregnancy;  Those who consume vitamin D and  taking antidiabetic drugs; People who follow a special diet pattern had specific physical activity</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sclerocystic ovary syndrome Stein-Leventhal syndrome</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: 8 vitamin D3 capsule 50000 IU during 2 month (1 capsule in the week after lunch)</i_keyword>
      <i_keyword>Control: 8 placebo capsule(Paraffinedible) during 2 month (1 capsule in the week after lunch)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insulin resistance. Timepoint: before intervention-after intervention (2 month later). Method of measurement: insulin resistance: HOMA-IR, HOMA-B ,QUICKI.</prim_outcome>
      <prim_outcome>Visceral fat. Timepoint: before intervention-after intervention(2 month later). Method of measurement: visceral fat :BIA(Inbody 770).</prim_outcome>
      <prim_outcome>Adiponectin. Timepoint: before intervention-after intervention(2 month later). Method of measurement: Adiponectin.: serum adiponectin.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sun exposure and physical activity. Timepoint: during intervention. Method of measurement: The questionnaire sunlight.</sec_outcome>
      <sec_outcome>Diet. Timepoint: week 4-6-8. Method of measurement: 24-hour recalls.</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, Urmia  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-18</approval_date>
        <contact_name>Ethics committee of Urmia  University of Medical Sciences</contact_name>
        <contact_address>University Campus: Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran Phone:+98 44 3223 4897 Fax: +98 44 322 290 59 Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
