<?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>IRCT2013092914809N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-11-30</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Hamedan University of Medical Science</primary_sponsor>
      <public_title>Effects of omega-3 supplements on prophylaxis of pediatric migraine</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial to comparison the effect of omega-3 supplements and placebo on pediatric migraine prophylaxis in children treated with valproate sodium</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14311</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Placebo capsules with the same color, package, and shape as omega-3 capsules are produced by Zahravi Pharmaceutical Company. Patients are considered in one of two groups, A or B, with simple random sampling method and the code will be assigned to each of them. The patient and physician are unaware of the contents of the medical groups. The patients will be treated by the physician and they will be followed for at least 3 months. The frequency and severity of headache will be registered. At the end of treatment and after the registration of patient information, codes will be unveiled.</study_design>
      <phase>2</phase>
      <hc_freetext>migraine.</hc_freetext>
      <i_freetext>Intervention 1: Twenty mg/kg/day valproate sodium daily in 2 divided doses with one omega-3 capsule contain of  1 gr fish oil, Produced by Zahravi Pharmaceutical Company, for 3 months  (intervention). Intervention 2: Twenty mg/kg/day valproate sodium daily in 2 divided doses with one placebo capsule (as the same color, package, and shape as omega-3 capsule without any active ingredient, Produced by Zahravi Pharmaceutical Company) for 3 months  (control).</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>Afshin Fayyazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Department, Besat Hospital, Shahid Motahari Blvd. Resalat Sq.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 811264002030</telephone>
        <email>afshin.fayyazi@yahoo.com</email>
        <affiliation>Hamedan University of Medical Science, School of Medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Fayyazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Department, Besat Hospital, Shahid Motahari Blvd. Resalat Sq.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 811264002030</telephone>
        <email>afshin.fayyazi@yahoo.com</email>
        <affiliation>Hamedan University of Medical Science, School of Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1.children in 5-14 years old age 2.Having migraine headache based on International Headache Society Criteria 3.Having frequent or disabling headaches that prophylactic therapy indicated in them (one or more headache attack per week or, three or more headache attacks per month or, more than one school day lost per month)                     &#13;
Exclusion Criteria: 1.Diagnosis changes each time during the study 2.Secondary headaches or other neurologic disorders 3.Not to use drugs correctly</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Twenty mg/kg/day valproate sodium daily in 2 divided doses with one omega-3 capsule contain of  1 gr fish oil, Produced by Zahravi Pharmaceutical Company, for 3 months  (intervention)</i_keyword>
      <i_keyword>Twenty mg/kg/day valproate sodium daily in 2 divided doses with one placebo capsule (as the same color, package, and shape as omega-3 capsule without any active ingredient, Produced by Zahravi Pharmaceutical Company) for 3 months  (control)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Monthly frequency of headache. Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient.</prim_outcome>
      <prim_outcome>Severity of headache. Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient.</prim_outcome>
      <prim_outcome>Pediatric Migraine Disability Grade (pedMIDAS). Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient.</prim_outcome>
      <prim_outcome>Clinical general impression. Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Omega-3 side effects including gastrointestinal side effects and allergy. Timepoint: Monthly until three months of treatment. Method of measurement: Clinical exam and asking from patients.</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 and Technology, Hamedan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-10</approval_date>
        <contact_name>Ethics Committee of Hamedan University of Medical Science</contact_name>
        <contact_address>School of Medicine, Shahid Fahmide Blvd. Pazhuhesh Crossroad Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
