<?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>IRCT20171003036539N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-15</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin D supplements on the treatment of diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of vitamin D injection on Endothelial Biomarkers, hs-CRP and  blood pressure in vitamin D deficient patients with Type 2 Diabeties</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40844</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 50people who have been admitted to the study, who had been previously visited by the doctor,using random codes from the computer (random allocation table), participants were classified into two groups (each group number꞊ 25) . Randomization was performed by computer-generated and using random location software. The number 1 through 50 were assigned in the intervention and control groups. The first person was given number one and the last was given number 50.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type II diabetes.</hc_freetext>
      <i_freetext>Intervention 1: injection of Vitamin D 400000 IU first and one month after the start of the study each time 200,000 IU Duration of study 2 months. Intervention 2: Control group: The control group does not receive anything.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>farhang Mirzavandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of Medical Sciences, Yazd, Iran.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 353538209143</telephone>
        <email>f.mirzavandi@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr hassan mozaffari-khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 353538209143</telephone>
        <email>mozaffari.kh@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetes mellitus patients and HbA1c hemoglobin less than 9
levels of hydroxyvitamin D (25 OHD) less than 20 ng / ml
Age range 30-60 years</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of vitamin D supplementation over the past 3 months-
Kidney,liver disease,Malabsorption syndrome,Severe infection
Pregnancy and lactation
Use of insulin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</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>injection of Vitamin D 400000 IU first and one month after the start of the study each time 200,000 IU Duration of study 2 months.</i_keyword>
      <i_keyword>Control group: The control group does not receive anything.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>P-selectin of serum. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: ELISA method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>High-sensitivity C-reactive protein (hs-CRP) of serum. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: ELISA method.</sec_outcome>
      <sec_outcome>Vitamin D of serum. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: ELISA method.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: Mercury barometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: Mercury barometer.</sec_outcome>
      <sec_outcome>Wight. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: scales.</sec_outcome>
      <sec_outcome>Serum Calcium. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Serum Phosphorus. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Intercellular Adhesion Molecule-1 of serum. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: ELISA method.</sec_outcome>
      <sec_outcome>Evalution of patients diet. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: Three-day food record.</sec_outcome>
      <sec_outcome>Beck Depression score. Timepoint: Before the intervention and two months after the start of the study. Method of measurement: Beck Depression Inventory2 score.</sec_outcome>
      <sec_outcome>Serum fasting blood sugar(FBS). Timepoint: Before the intervention and two months after the start of the study. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Serum triglyceride level (TG). Timepoint: Before the intervention and two months after the start of the study. Method of measurement: Enzymatic method.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-17</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Sciences Yazd</contact_name>
        <contact_address>Yazd - Alam Square - Anonymous Martyrs Blvd - Campus of Shahid Sadoughi University of Medical Sciences Yazd - Yazd School of Public Hea Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
