<?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>IRCT2016021125732N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-01</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Semnan University of Medical sciences</primary_sponsor>
      <public_title>Clinical and laboratory Efects of vitamin D supplementation  in adolescent  with polycystic ovarian syndrome and vitamin D deficiency</public_title>
      <acronym></acronym>
      <scientific_title>Clinical and laboratory Efects of vitamin D supplementation  in adolescent  with polycystic ovarian syndrome and vitamin D deficiency</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21479</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Adolescent with polycystic ovarian syndrome and vitamin D deficiency.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, 50 000 IU of vitamin D weekly for 8 weeks will be given.&#13;
PCOS symptoms, patients should not interfere with effective drugs such as oral contraceptives COCS, metformin, medroxyprogesterone and so on. The only injectable progesterone injections in case of amenorrhea has 45 days from the previous cycle dose of 200 mg intramuscularly for induction menstruation is used. Intervention 2: The control group, placebo will be given for 8 weeks.&#13;
PCOS symptoms, patients should not interfere with effective drugs such as oral contraceptives COCS, metformin, medroxyprogesterone and so on. The only injectable progesterone injections in case of amenorrhea has 45 days from the previous cycle dose of 200 mg intramuscularly for induction menstruation is used.</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 Mojgan Rahmanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hospital AmirAlMomenin, Mostafa Khomeini Blvd, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3345 1336</telephone>
        <email>are20935@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences, Vice Chancellor for Research, Semnan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mojgan Rahmanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hospital AmirAlMomenin, Mostafa Khomeini Blvd, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3345 1336</telephone>
        <email>are20935@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 14 to 18 years old; people with impaired ovulation or anovulation for oligoovulation (oligo- and / or anovulation); 2 and 3 Hyperandrogenemia clinical hyperandrogenism or There polycystic ovarian morphology on ultrasound and they are deficient in vitamin D, and the study Azargoon et al(1) known as polycystic ovarian syndrome.&#13;
Exclusion criteria: people who do not have full consent to participate in this study; Those who did not use vitamin D to regular weekly; Those in the intervention of the symptoms of polycystic ovary syndrome drugs such as birth control pills, metformin, medroxyprogesterone and progesterone intramuscular injection except in the event of amenorrhea has 45 days from the previous cycle dose of 200 mg for the induction periods are used.</inclusion_criteria>
      <agemin>80 years</agemin>
      <agemax>76 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2 ; E2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome; Ovarian dysfunction, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, 50 000 IU of vitamin D weekly for 8 weeks will be given.&#13;
PCOS symptoms, patients should not interfere with effective drugs such as oral contraceptives COCS, metformin, medroxyprogesterone and so on. The only injectable progesterone injections in case of amenorrhea has 45 days from the previous cycle dose of 200 mg intramuscularly for induction menstruation is used.</i_keyword>
      <i_keyword>The control group, placebo will be given for 8 weeks.&#13;
PCOS symptoms, patients should not interfere with effective drugs such as oral contraceptives COCS, metformin, medroxyprogesterone and so on. The only injectable progesterone injections in case of amenorrhea has 45 days from the previous cycle dose of 200 mg intramuscularly for induction menstruation is used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring vitamin D. Timepoint: Started. Method of measurement: Laboratory - using the kit for measuring vitamin D, with EUROIMMUN, the UK.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ultrasonography. Timepoint: In 3 to 5 days of menstrual bleeding. Method of measurement: Abdominal Ultrasonography, by one sonographer.</sec_outcome>
      <sec_outcome>Measuring vitamin D. Timepoint: After the intervention. Method of measurement: Laboratory - using the kit for measuring vitamin D, with EUROIMMUN, the UK.</sec_outcome>
      <sec_outcome>Blood pressure measurement. Timepoint: After the intervention. Method of measurement: Manometer using a pan with 710 made in Taiwan, the left arm in a sitting position.</sec_outcome>
      <sec_outcome>Measure weight. Timepoint: After the intervention. Method of measurement: Scales with 100 g.</sec_outcome>
      <sec_outcome>Measuring stature. Timepoint: After the intervention. Method of measurement: Using tape measure with an accuracy of one centimeter.</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, Semnan University of Medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-25</approval_date>
        <contact_name>Ethics Committee of the Semnan University of Medical sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
