<?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>IRCT20151128025267N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effects of vitamin D on migraine headache and its possible associated factors</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effects of viamin D on CGRP levels, inflammatory markers, Treg/Th17 balance and episodic migraine characteristics in Adult migraineurs</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31246</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The duration of this randomized, double-blind, placebo controlled trial will be 16 weeks, consisting of 4-week of baseline following by 12-week intervention. Also, patients will be instructed to fill out a headache diary designed by our headache specialist neurologist in order to provide headache characteristics including headache severity, duration of attacks, number of attacks, and number of days with headache in the month. Patients will be asked to not change their medications during the study, Randomization description: according to double-blind nature of this trial, from the beginning of the study, A and B codes are available to researchers to recruit the patients using twenty 4-Block Randomization, Blinding description: Only one of the staff of the headache department is aware of the type of assigned intervention for each patient (vitamin D or placebo, which are marked by A or B codes). Finally, after collecting the data, she unseals the codes for researchers, the statistical analyst, and those who prepare the manuscript.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>migraine headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intervention group will receive 1 capsule which contains 2000 of vitamin D every day for 12 weeks. Intervention 2: Control group:  placebo group will receive 1 capsule of placebo with the same smell and taste as vitamin D during 12-week period.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Maryam Mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No: 44 Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14155-6117</zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>m-mahmoudi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Naderi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14155-6117</zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>zghorbani@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having BMI between 18.5-30 kg/m2
Migraine diagnosis according to The International Classification of Headache Disorders 3rd edition
having 3-15 migraine headache attacks in last 3 months
suffering from migraine for at least 6 months prior to study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>unwillingness to participate in the study
daily consumption of NSAIDs in 3 months prior to study
taking vitamin D supplements in 3 months prior to study
taking magnesium, calcium, zinc, vitamin B groups and vitamin C supplements during the study period
taking anti-epileptic drugs such as topiramate,  sodium valproate and carbamazepine
taking thiazide diuretics, Glucocorticoid, statins and orlistat
taking anti-psychotic drugs
menopause
pregnancy and lactation
suffering from gastrointestinal disorders (IBD, IBS,...), liver and kidney disorders, cancer, Sarcoidosis, rickets, and osteomalacia based on physician diagnosis and/or past medical history</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intervention group will receive 1 capsule which contains 2000 of vitamin D every day for 12 weeks</i_keyword>
      <i_keyword>Control group:  placebo group will receive 1 capsule of placebo with the same smell and taste as vitamin D during 12-week period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Migraine attack frequency per month. Timepoint: baseline-end of study. Method of measurement: headache diary.</prim_outcome>
      <prim_outcome>Attack severity. Timepoint: baseline-end of study. Method of measurement: headache diary-visual analogue scale.</prim_outcome>
      <prim_outcome>Headache attack duration (min per month). Timepoint: baseline-end of study. Method of measurement: headache diary-visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum 25 (OH) D3. Timepoint: baseline- end of study. Method of measurement: laboratory test.</sec_outcome>
      <sec_outcome>Serum vitamin D receptor. Timepoint: baseline- end of study. Method of measurement: laboratory test.</sec_outcome>
      <sec_outcome>Determining inflammatory status (including serum levels of iNOS, IL 6, Cox 2, CGRP, and IL10 ). Timepoint: baseline- end of study. Method of measurement: laboratory test.</sec_outcome>
      <sec_outcome>Determining Treg/th17 balance (including serum levels of TGF b and IL-17). Timepoint: baseline- end of study. Method of measurement: laboratory test.</sec_outcome>
      <sec_outcome>Serum prolactin levels. Timepoint: baseline- end of study. Method of measurement: laboratory test.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Tehran University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-08</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Ghods Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
