<?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>IRCT2017031133014N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-06</date_registration>
      <primary_sponsor>Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin D in vitiligo patients</public_title>
      <acronym>-</acronym>
      <scientific_title>The effectiveness of vitamin D compared with placebo in vitiligo patients treated with Narrow Band UVB: A randomized control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25575</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization will be performed through block randomization  method with the blocks of 6. In this method, the randomization will be done until the third person will be randomly assigned to a group, after which the individuals will be allocated to the other group automatically until the 6th blocks will be completed.</study_design>
      <phase>1</phase>
      <hc_freetext>Vitiligo.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pearl VIT D 50000 unit, Orally, on pearl every 2 weeks, for 2 months Plus Narrow Band UVB, 0.3 J / CM2. Intervention 2: Control group: Placebo, Orally, Every 2 weeks a number for 2 months Plus Narrow Band UVB, 0.3 J / CM2.</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>Dr Zahra ALsadat Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Skin Ward, Imam Khomeini Hospital, 24 Metry Street, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 21 2245 6080</telephone>
        <email>nafmousavi@gmail.commousavi.z@ajums.ac.ir</email>
        <affiliation>Skin Ward, Ahvaz Imam Khomeini Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Omidian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Skin Ward, Imam Khomeini Hospital, 24 Metry Street, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 612222922</telephone>
        <email>momidian@yahoo.com</email>
        <affiliation>Skin Ward, Ahvaz Imam Khomeini Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with generalized vitiligo or skin lesions equal or more than five percent of the body surface. Exclusion criteria: patients with hemodialysis and renal failure; receiving thiazide diuretics, lithium utilization; get systemic treatment in the last month; increasing serum leading to drug toxicity; age under 6 years old; phototherapy sessions less than 2 times a week.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vitiligo</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: Pearl VIT D 50000 unit, Orally, on pearl every 2 weeks, for 2 months Plus Narrow Band UVB, 0.3 J / CM2.</i_keyword>
      <i_keyword>Control group: Placebo, Orally, Every 2 weeks a number for 2 months Plus Narrow Band UVB, 0.3 J / CM2.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in the extent of skin involvement. Timepoint: Every 2 months until 4 months. Method of measurement: Based on Vitiligo Area Scoring Index (VASI) Score. In this method body is divided into five separate regions: the hands, upper extremities, trunk,lower extremities and feet. The face and neck areas are assessed separately. One hand unit of the patient (the palm plus the volar surface of the digits) is used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. For each body region, VASI is determined as the product of the vitiligo area in hand units (set at 1% per unit) and the pattern of depigmentation within each hand-unit-measured patch (possible values of 10, 25,50, 75, 90 or 100%, which are illustrated with a descrip-tive atlas of patient photographs). VASI, applied to the whole body, will calculated using the following formula, (possible range 0–100): all body sites (hand units) × depigmentation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum 25-hydroxyvitamin D level. Timepoint: At the beginning and at the 11th week of the study. Method of measurement: Blood test.</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, Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-27</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Shahre Daneshgahi, Ahvaz Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
