<?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>IRCT20190410043236N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-08</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of vitamin D on improvement of left ventricular ejection fraction in patients with systolic heart failure</public_title>
      <acronym></acronym>
      <scientific_title>Effect of vitamin D on improvement of left ventricular ejection fraction in patients with systolic heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38837</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In present study, simple randomization method was used, Blinding description: This double-blind study was carried out and the cardiologist who do echocardiography patients, as well as those taking medication or placebo, are blind.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Systolic Heart failure. Condition 2: Systolic Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: A 50000 unit capsule of vitamin D, manufactured by Abidi company, is given weekly and at 50,000 units for 8 weeks. It should be noted that patients will not be aware of the type of medicine. Patients are monitored for 2 months. Intervention 2: Placebo group: Appearance of 50,000 capsules of vitamin D, manufactured by Abidi company, is given weekly for 8 weeks. It should be noted that patients will not be aware of the type of medicine. Patients are monitored for 2 months.</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:
Data files related to the use of medication and medication are also the main implications of sharing.

When:
The beginning of the access period was 1 year after the publication

To whom:
Data and other study documentation will be available to all individuals and academic and non-academic institutions.

Conditions:
Individuals with data receiving conditions can have the data available after receiving the documented consent of Zanjan University of Medical Sciences

Where to obtain:
Visit Zanjan University of Medical Sciences at your personal or e-mail address and get consent for received information.

How to obtain:
Individuals or institutions, in person or by email, with his introduction and explanation of the purpose of the visit to the Zanjan University of Medical Sciences has the opportunity to have information and can have information within about 1 month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Reza Hassanzadeh Makuei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Mousavi Hospital-Gawazang Road</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5235255225</zip>
        <telephone>+98 24 3353 4019</telephone>
        <email>makuei42@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Reza Hassanzadeh Makuei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Mousavi Hospital-Gavazang Road</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5225665855</zip>
        <telephone>+98 24 3353 4019</telephone>
        <email>makuei42@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Chronic heart failure with 20%≤EF≤45% (based on Framingham criteria, NYAH Class I, II, III)
The level of 25 (OH) Vit D is less than 30 ngr / dl
Age over 40 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hypercalcemia
Osteomalacia
Taking corticosteroid medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>130-152</hc_code>
      <hc_code>150.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>IX Diseases of the circulatory system</hc_keyword>
      <hc_keyword>Left ventricular failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: A 50000 unit capsule of vitamin D, manufactured by Abidi company, is given weekly and at 50,000 units for 8 weeks. It should be noted that patients will not be aware of the type of medicine. Patients are monitored for 2 months.</i_keyword>
      <i_keyword>Placebo group: Appearance of 50,000 capsules of vitamin D, manufactured by Abidi company, is given weekly for 8 weeks. It should be noted that patients will not be aware of the type of medicine. Patients are monitored for 2 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ejection Fraction. Timepoint: Before beginning the intervention with vitamin D and placebo and then 2 months after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>End Diastolic Volume. Timepoint: Before beginning the intervention with vitamin D and placebo and then 2 months after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Heart Failure Class. Timepoint: Before beginning the intervention with vitamin D and placebo and then 2 months after the intervention. Method of measurement: Echocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vitamin D. Timepoint: Before the intervention, then two months after the intervention with vitamin D and placebo. Method of measurement: High Performance Liquid Chromatography.</sec_outcome>
      <sec_outcome>Albumin. Timepoint: Before the intervention, then two months after the intervention with vitamin D and placebo. Method of measurement: Immunoassay.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: Before the intervention, then two months after the intervention with vitamin D and placebo. Method of measurement: Immunoassay.</sec_outcome>
      <sec_outcome>Calcium. Timepoint: Before the intervention, then two months after the intervention with vitamin D and placebo. Method of measurement: Ion Selected (Specific) Electrode.</sec_outcome>
      <sec_outcome>Phosphor. Timepoint: Before the intervention, then two months after the intervention with vitamin D and placebo. Method of measurement: Ion Selected (Specific) Electrode.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-14</approval_date>
        <contact_name>Zanjan University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Azad Blv.- Headquarters of Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
