<?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>IRCT20251116068013N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-13</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of vitamin D on headache severity in adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of vitamin D on headache severity in adolescents with migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88429</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to either the intervention or control group using a Block Randomization method with a block size of 4 and an allocation ratio of 1:1. The randomization sequence will be generated by an independent individual (not involved in clinical care or assessment) using computer-generated random numbers. To ensure Allocation Concealment, sequentially numbered, opaque, sealed envelopes will be used. Upon enrollment, each participant will be assigned a serial number and will receive the corresponding envelope to determine their group assignment, Blinding description: To implement blinding, vitamin D supplements will be provided in identical packaging so that the participants (adolescents) remain unaware of their group assignments. Furthermore, the outcome assessor (pediatric neurologist), who evaluates headache severity using the VAS scale and records the frequency of attacks at the end of the third month, will be blinded to the group allocations. Additionally, the statistical analyst will remain blinded to the group identities until the completion of the data analysis process.</study_design>
      <phase>3</phase>
      <hc_freetext>Migraine in children and adolescents.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receives 1000 IU of Vitamin D supplement orally per day for 3 months. In addition, routine treatment including Propranolol tablets (20 mg every 12 hours) and Amitriptyline tablets (25 mg at night) is prescribed. Intervention 2: The control group receives only the routine treatment including Propranolol tablets (20 mg every 12 hours) and Amitriptyline tablets (25 mg at night) for 3 months and will not receive Vitamin D supplements.</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 Individual participant data will not be shared beyond the final results of the study to maintain patient confidentiality.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Kouhbanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice Chancellor for Research and Technology, Birjand University of Medical Sciences Central Site, Ghaffari St, Birjand, Iran.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۹۶۳۱۱۴</zip>
        <telephone>+98 992 461 5428</telephone>
        <email>mohammadkbn2@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahya Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite Birjand University of Medical Sciences, Zakariya Razi St, Ghaffari St, Birjand, South Khorasan, Iran</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۹۶۳۱۱۴</zip>
        <telephone>+98 56 3239 5000</telephone>
        <email>hosseini.mahia66@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adolescents aged between 10 and 18 years
Definitive diagnosis of migraine by a pediatric neurologist based on ICHD-3 criteria
Serum vitamin D levels less than 30 ng/ml (deficiency or insufficiency)
Willingness to participate and providing informed consent by parents or legal guardians
Absence of chronic underlying diseases (cardiac, renal, or hepatic)</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Affliction with chronic systemic diseases (including cardiovascular, renal, hepatic diseases, and hyperthyroidism or hypothyroidism)
Use of vitamin D supplements in the past three months
Consumption of medications affecting vitamin D metabolism (such as specific anticonvulsants or corticosteroids)
Presence of morbid obesity (Body Mass Index or BMI &gt; 30 kg/m²)
Diagnosis of Diabetes Mellitus
Reluctance of the patient or parents to continue participation at any stage of the study
Occurrence of severe adverse effects or hypersensitivity to vitamin D supplementation</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receives 1000 IU of Vitamin D supplement orally per day for 3 months. In addition, routine treatment including Propranolol tablets (20 mg every 12 hours) and Amitriptyline tablets (25 mg at night) is prescribed.</i_keyword>
      <i_keyword>The control group receives only the routine treatment including Propranolol tablets (20 mg every 12 hours) and Amitriptyline tablets (25 mg at night) for 3 months and will not receive Vitamin D supplements.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache intensity. Timepoint: Before intervention (Baseline), 1, 2, and 3 months after the start of interventio. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Duration of headache in hours per day. Timepoint: Before intervention and one month after the intervention and two months after intervention and three months after the intervention. Method of measurement: Daily recording with timer.</prim_outcome>
      <prim_outcome>Number of the patient’s headache attacks per month. Timepoint: Monthly. Method of measurement: Daily recording.</prim_outcome>
      <prim_outcome>Vitamin D. Timepoint: Before and after intervention. Method of measurement: Laboratory measurement of Vitamin D.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-14</approval_date>
        <contact_name>Research Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Ghafari Blvd Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
