<?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>IRCT20180118038423N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Can Vitamin D reduce heart damage in  cardiac surgery</public_title>
      <acronym></acronym>
      <scientific_title>association between vitamin D administration and pathological feature of cardiac cell  in patients with low Vitamin D who are candidates for coronary artery bypass graft(CABG) surgery for the first time</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29535</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Method of randomization was simple and its unit was individuals.we used a computer software for randomization.For allocation concealment all of the ICU  nurses that took care of patients, lab technicians who did the ELISA, pathologist who did the IHC and all the patients were not aware of the randomization process, Blinding description: Each patient will assign to a specific code and they will receive a same looking drug.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Vitamin d deficiency. Condition 2: Ischemic hypertrophy heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 33 patients that receive  placebo for 3 days before the surgery and each day 3 doses. Intervention 2: Intervention group: A 33 patients that receive Vitamin D for 3 days before and each days 3 doses of 50000 units of Vitamin D made by Zahravi company.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All of the information

When:
starting 6 months after publication

To whom:
researcher and artisans

Conditions:
Just for researcher in a same field and for pharmaceutical companies to see whether they should a drug produce and or import

Where to obtain:
Cardiac surgery research center in Shahid Modarres hospital 
Dr.Mahnoosh Foroughi
Erfan Tasdighi researcher 
Email: erfan.tasdighi@gmail.com

How to obtain:
We will decide to accept or reject the application after a session in research center

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Erfan Tasdighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velenjak-Daneshju squer -Daneshju street-Shahid beheshti medical university</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8781264569</zip>
        <telephone>+98 21 23871</telephone>
        <email>erfan.tasdighi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnoosh Foroughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Province, Tehran, District 2, Saadat Abad Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5264987565</zip>
        <telephone>+98 21 2207 4092</telephone>
        <email>mahnoosh.foroughi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients that have CABG surgery for the first time
patients only with coronary surgery and no valvular surgery
patients that we use cardipulmonary pump during the surgery
patients with vitamin D level less than 30 ng/ml</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have Renal failure
creatinine higher than 1.5 mg/dl</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E55</hc_code>
      <hc_code>I25.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vitamin D deficiency</hc_keyword>
      <hc_keyword>Ischemic cardiomyopathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 33 patients that receive  placebo for 3 days before the surgery and each day 3 doses</i_keyword>
      <i_keyword>Intervention group: A 33 patients that receive Vitamin D for 3 days before and each days 3 doses of 50000 units of Vitamin D made by Zahravi company</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caspase 2 enzyme level. Timepoint: Right after intervention(3 days before surgery)-The day of surgery -Next day after surgery. Method of measurement: Immunohistochemstry.</prim_outcome>
      <prim_outcome>Caspase 3 enzyme level. Timepoint: Right after intervention(3 days before surgery)-The day of surgery -Next day after surgery. Method of measurement: Immunohistochemistery.</prim_outcome>
      <prim_outcome>Caspase 7 enzyme level. Timepoint: Right after intervention(3 days before surgery)-The day of surgery -Next day after surgery. Method of measurement: Immunohistochemistery.</prim_outcome>
      <prim_outcome>IL-10 serum level. Timepoint: Right after intervention(3 days before surgery)-The day of surgery -Next day after surgery. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Insulin growth factor. Timepoint: Right after intervention(3 days before surgery)-The day of surgery -Next day after surgery. Method of measurement: blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemorrhage after surgery. Timepoint: Right after surgery. Method of measurement: Suction.</sec_outcome>
      <sec_outcome>Blood units usage. Timepoint: During the surgery and after that. Method of measurement: Number of blood units.</sec_outcome>
      <sec_outcome>How lung we used the ventilator. Timepoint: Since the surgery. Method of measurement: ventilator.</sec_outcome>
      <sec_outcome>Kidney damage. Timepoint: After surgery. Method of measurement: blood test.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>35981</sec_id>
        <issuing_authority>ISRCTN registry</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-04</approval_date>
        <contact_name>ethics committee of Shahid Beheshti medical university</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
