<?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>IRCT2016102615111N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-24</date_registration>
      <primary_sponsor>Vice Chancellor for research, Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin D on prevention of Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The comparative study of the effect of fortified yogurt with vitamin D, plain yogurt and vitamin D supplement on Glycemic, lipid and anthropometric indices in people with pre-diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14492</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: In This study receiving groups of fortified yogurt and plain yogurt and researchers will be blind about nature of yogurts.&#13;
The random placement of subjects in intervention groups is based on the random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prediabetes.</hc_freetext>
      <i_freetext>Intervention 1: Riched yogurt (100cc/day) with 1000 IU Vitamin D reciving group&#13;
&#13;
&#13;
Intervention Duration: 3 month. Intervention 2: vitamin D supplement (1000 IU/day) receiving group. Intervention 3: plain yoghurt (100cc/day) reciving group.</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>Roghayeh Mostafai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Public Health faculty, Next to the Farabi Hospital, Dolat Abad blvd, Isar Square, Imam Hosein Exp</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+98 83 3827 6394</telephone>
        <email>r_mostafai@yahoo.com</email>
        <affiliation>Public Health faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mostafa Nachvak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Public Health faculty, Next to the Farabi Hospital, Dolat Abad blvd, Isar Square, Imam Hosein Exp</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+98 83 3826 2052</telephone>
        <email>Smnachvak@hotmail.com</email>
        <affiliation>Faculty of Health</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : Full consent of the individual, 25-65 years old, not family history of diabetes, lack of other chronic diseases (coronary heart, liver, kidney, thyroid, parathyroid, malabsorption, ...) or special circumstances such as pregnancy and breastfeeding, avoiding the use of any supplements or drugs and no smoking. Exclusion criteria :lack of interest in the continuation of cooperation, failure to follow the consumption of specified amount of fortified yogurt with vitamin D, plain yogurt and vitamin D supplement and require to use of oral anti diabetic drug.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10, E11, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Riched yogurt (100cc/day) with 1000 IU Vitamin D reciving group&#13;
&#13;
&#13;
Intervention Duration: 3 month</i_keyword>
      <i_keyword>vitamin D supplement (1000 IU/day) receiving group</i_keyword>
      <i_keyword>plain yoghurt (100cc/day) reciving group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>HbA1c. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pishtazteb HbA1c Kit.</prim_outcome>
      <prim_outcome>2h-OGTT. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon OGTT  Kit.</prim_outcome>
      <prim_outcome>Vitamin D. Timepoint: Befor and 3 month after of intervention. Method of measurement: Vitamin D MONOBIND Kit.</prim_outcome>
      <prim_outcome>Ca. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon Calcium Kit.</prim_outcome>
      <prim_outcome>Serum insulin. Timepoint: Befor and 3 month after of intervention. Method of measurement: Insulin MONOBIND Kit.</prim_outcome>
      <prim_outcome>FBS. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon glucose kit.</prim_outcome>
      <prim_outcome>T-chol. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon Cholesterol Kit.</prim_outcome>
      <prim_outcome>LDL-c. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon LDL- c Kit.</prim_outcome>
      <prim_outcome>HDL-c. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon HDL- c Kit.</prim_outcome>
      <prim_outcome>TG. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon Triglyceride Kit.</prim_outcome>
      <prim_outcome>ALT. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon ALT  Kit.</prim_outcome>
      <prim_outcome>AST. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon AST  Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>FBS. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon glucose kit.</sec_outcome>
      <sec_outcome>Serum insulin. Timepoint: Befor and 3 month after of intervention. Method of measurement: Insulin MONOBIND Kit.</sec_outcome>
      <sec_outcome>TG. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon Triglyceride Kit.</sec_outcome>
      <sec_outcome>Vitamin D. Timepoint: Befor and 3 month after of intervention. Method of measurement: Vitamin D MONOBIND Kit.</sec_outcome>
      <sec_outcome>Ca. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon Calcium  Kit.</sec_outcome>
      <sec_outcome>HbA1c. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pishtazteb HbA1c Kit.</sec_outcome>
      <sec_outcome>T-chol. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon Cholesterol Kit.</sec_outcome>
      <sec_outcome>LDL-c. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon LDL- c  Kit.</sec_outcome>
      <sec_outcome>HDL-c. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon HDL- c  Kit.</sec_outcome>
      <sec_outcome>2h-OGTT. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon OGTT  Kit.</sec_outcome>
      <sec_outcome>ALT. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon ALT Kit.</sec_outcome>
      <sec_outcome>AST. Timepoint: Befor and 3 month after of intervention. Method of measurement: Pars azmon AST  Kit.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Damdaran Company of Dairy</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, Kermanshah University of Medical Sciences</source_name>
      <source_name>Damdaran Company of Dairy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-19</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
