<?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>IRCT2017010131695N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-29</date_registration>
      <primary_sponsor>Vice chancellor for research,  Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin D supplementation in the prevention of recurrence of preeclampsia in pregnant women with a history of preeclampsia</public_title>
      <acronym></acronym>
      <scientific_title>The effect of vitamin D supplementation in the prevention of recurrence of preeclampsia in pregnant women with a history of preeclampsia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>142</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24879</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, then matching the inclusion and exclusion criteria and obtaining informed consent, pregnant women were assigned  to intervention and control groups randomly,by using random number table.Study participants are unaware of assignment in to the intervention or control groups.Physician is not aware of each patient's group.</study_design>
      <phase>3</phase>
      <hc_freetext>preeclampsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1 : &#13;
Administration of Vitamin D3, 50000  IU ,pearl. Intervention 2: intervention 2: Administration of placebo.</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>Shole Shah Gheibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat hospital,  Keshavarz Blvd, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66196-67761</zip>
        <telephone>+98 87 3328 2001</telephone>
        <email>shahgheibi@yahoo.com</email>
        <affiliation>Besat Hospital, Sannandaj</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Zandvakili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat Hospital, Keshavarz Blvd, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66196-67761</zip>
        <telephone>+98 87 3328 2001</telephone>
        <email>Dr.zandvakili.f.@gmail.com</email>
        <affiliation>Kurdestan University of  Medical Science.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : pregnancy , history of preeclampsia in a previous pregnancy , blood levels of vitamin D above 32 nanograms per milliliter&#13;
Exclusion criteria : the risk of chronic hypertension before pregnancy , chronic kidney disease associated pulmonary and cardiovascular , immunological diseases such as lupus , the uncertainty of patient cooperation in the study , immigration or study leave.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>o14.0 , o1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gestational [pregnancy-induced] hypertension with significant proteinuria Excl.: superimposed pre-eclampsia (O11) O14.0 Moderate pre-eclampsia O14.1 Severe pre-eclampsia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1 : &#13;
Administration of Vitamin D3, 50000  IU ,pearl</i_keyword>
      <i_keyword>intervention 2: Administration of placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic and Diastolic blood pressure. Timepoint: In initiation of study, 2 week after intervention, per 2 week to termination of pregnancy. Method of measurement: Blood pressure  is measured in the sitting position by using mercury barometer.</prim_outcome>
      <prim_outcome>Proteinuria. Timepoint: If there is a blood pressure greater than or equal to 140/90 mm Hg. Method of measurement: laboratory kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Preeclampsia Recognition. Timepoint: After 28 weeks of pregnancy. Method of measurement: Measurement of blood pressure  by using barometer, clinical symptoms and proteinuria detection by using laboratory kit.</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,  Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-26</approval_date>
        <contact_name>Ethics committee of kurdistan University of Medical Science</contact_name>
        <contact_address>Kurdistan University of Medical Sciences, Pasdaran Blvd. Sanandaj. Sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
