<?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>IRCT201305212324N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-18</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin D on severity of  primary dysmenorrhea and amount of menstrual bleeding</public_title>
      <acronym></acronym>
      <scientific_title>The effect of vitamin D on severity of  primary dysmenorrhea and amount of menstrual bleeding compared with placebo in students living in dormitories of  Tehran University of Medical Sciences: &#13;
Randomized, Double-blind, clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1964</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Contorol group will be received oral tablet of placebo, 2 tablets every 8 hours, 5 days before the putative beginning of their next menstrual cycle. Intervention 2: Case group will be received oral tablet of cholecalciferol (50000 IU of cholecalciferol), 2 tablets every 8 hours, 5 days before the putative beginning of their next menstrual cycle.</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>Elham Ghorbali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat Eastern St, Tohid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4219</telephone>
        <email>elhamghorbali@yahoo.com; elhamghorbali@gmail.com</email>
        <affiliation>School of Nursing and Midwifery, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Keshavarz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery dep, School of Nursing Midwifery, Iran University of Medical Sciences, Rashid Yasami St, Vanak Sq, Tehran.Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6105 4219</telephone>
        <email>Keshavarz.m@iums.ac.ir; m_keshir@yahoo.com</email>
        <affiliation>School of  Nursing and Midwifery, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Healthy, iranian and single female students aged 18 to 25 years؛ With normal menstrual cycles (cycles lasted 21 to 35 days,  mensturation lasting 3 to 7 days)؛ Experienced at least 4 consecutive painful periods in the past 6 months with the pain starting a few hours before or just after the onset of bleeding؛ No history of underlying disease cause of secondary dysmenorrhea sush as: endometriosis and adenomyosis,etc؛ Don’t do any regular exercise؛ Lack of stressful experiences within 3 months prior؛ Don’t use of oral contraceptives and hormonal drugs within 3 months prior؛ Taking no medications including calcium and vitamin D within 6 months prior؛ 25(OH)D serum level ≤ 30 ng/ml and normal serum calcium؛ Having no unusual diets (vegetarian diets, special diet)؛ Don’t use of  medicines that interact with vitamin D such as: hydantoin and barbiturates,etc؛ BMI ≤ 30؛ No smoking and alcohol consumption.   &#13;
&#13;
Exclusion criteria: Lack of menstruation؛ Married during the study؛ Use of medications including calcium and vitamin D during the study؛ Use of oral contraceptives and hormonal drugs during the study ؛Use of non-pharmacological methods of pain relief ؛Intense psychological stress during the study؛ Start exercise during the study ؛Don’t use of supplement or interventions intended ؛Occurring gastrointestinal disorders after the consumption of supplement (Including vomiting 2 hours after the consumption of supplement ؛(Unwillingness to continue research.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>primary dysmenorrhea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Contorol group will be received oral tablet of placebo, 2 tablets every 8 hours, 5 days before the putative beginning of their next menstrual cycle.</i_keyword>
      <i_keyword>Case group will be received oral tablet of cholecalciferol (50000 IU of cholecalciferol), 2 tablets every 8 hours, 5 days before the putative beginning of their next menstrual cycle.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score of primary dysmenorrhea. Timepoint: Before intervention,  the first cycle after intervention, the Second cycle  after intervention. Method of measurement: visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Amount of  menstrual bleeding. Timepoint: Before intervention,  the first cycle after intervention, the Second cycle  after intervention. Method of measurement: Pictorial blood loss assessment chart.</prim_outcome>
      <prim_outcome>Severity of primary dysmenorrhea. Timepoint: Before intervention,  the first cycle after intervention, the Second cycle  after intervention. Method of measurement: Verbal multidimensional scoring system (VMS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Use of NSAIDs. Timepoint: Before intervention,  the first cycle after intervention, the Second cycle  after intervention. Method of measurement: Record sheet of NSAID use.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>no</sec_id>
        <issuing_authority>no</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-24</approval_date>
        <contact_name>Ethical commitment of Tehran University of Medical Sciences</contact_name>
        <contact_address>Sixth floor ,Central office, Ghods St, Keshavarz Blvd- Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
