<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01695460</url>
  </required_header>
  <id_info>
    <org_study_id>N-20120052</org_study_id>
    <secondary_id>Projekt #831302</secondary_id>
    <nct_id>NCT01695460</nct_id>
  </id_info>
  <brief_title>A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine</brief_title>
  <official_title>A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CCBR Aalborg A/S, Aalborg, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial is primarily designed to investigate whether treatment with vitamin D may influence&#xD;
      migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve&#xD;
      as a prophylactic treatment of migraine. The hypothesis is tested by examining the changes in&#xD;
      the pain and symptom patterns associated with migraine by treatment with Vitamin D, by means&#xD;
      of quantitative sensory testing, diaries and blood samples for measurement of vitamin D.&#xD;
      Other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in&#xD;
      the blood is changed by the treatment with vitamin D. The hypothesis here is that levels of&#xD;
      those biomarkers will change following the treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of migraine attacks</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>The primary endpoint is the frequency of migraine attacks. This is estimated from the subjects' listing of attacks in the form of diaries. This is assessed as the number of migraine attacks per 4 weeks (28 days).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pain during migraine attacks</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>Evaluation of pain during migraine attacks carried out by the subjects themselves by completing diaries. The diaries trial participants evaluate the pain intensity during an attack using a 1-3 scale, where 1 is mild pain, 2 is moderate pain, and 3 severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypersensitivity</measure>
    <time_frame>Baseline and every 4 weeks</time_frame>
    <description>allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Migraine Symptoms</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative Sensory Testing</measure>
    <time_frame>Every 4 weeks</time_frame>
    <description>Pain Pressure Threshold and temporal summation are measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring levels of a biomarker. Changes in the levels of these biomarkers.</measure>
    <time_frame>Baseline and after 6 months treatment (end of trial)</time_frame>
    <description>Changes in the levels of these biomarkers are measured:&#xD;
25(OH)D, 1,25(OH)D, GFAP, S100B, CGRP,Glutamate, Serotonin, Prostaglandin E2</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>Every 28 days</time_frame>
    <description>HIT-6 (Headache Impact Test)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Migraine According to International Headache Society (IHS) Criteria (ICHD-II)</condition>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The active treatment consists of vitamin D and is given in tablets of the brand D3 Vitamin ®, supplied by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg.&#xD;
The tablets contain the vitamin D in the form of vitamin D3, also known as cholecalciferol.&#xD;
D3 Vitamin ® consists of small white tablets, which are easy to swallow.&#xD;
D3 Vitamin ® contains 25 micrograms vitamin D3 (colecalciferol) per tablet, equivalent to 1000 IU (International Units).&#xD;
Tablet Excipients: Cellulose, dicalcium phosphate, magnesium stearate, silicon dioxide and talc. Vitamin D3 ® contains no gluten, soy, gelatin or other animal products.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets to match D3 Vitamin ®, were produced. They are identical to the D3 Vitamin ® in appearance, ie small white tablets. These tablets do not have a therapeutic effect. Placebo tablets produced and delivered by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D3 Vitamin ®</intervention_name>
    <description>Vitamin D and placebo supplied as tablets in containers of 124. The containers must be kept in dry and not too hot environment.&#xD;
All subjects randomized to vitamin D, will receive 100 micrograms of vitamin D3/day, equivalent to 4000 IU. Vitamin D is administered orally 1 time a day with breakfast.</description>
    <arm_group_label>Vitamin D</arm_group_label>
    <other_name>D3 Vitamin ®, supplied by D3 Pharmacy Ltd</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women between 18 and 65, migraine must have occurred before the age of 50&#xD;
             years.&#xD;
&#xD;
          -  Diagnosed migraine according to International Headache Society (IHS) criteria&#xD;
             (ICHD-II)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other neurological or neurodegenerative disorders&#xD;
&#xD;
          -  Medical conditions that may interfere with the result - violent head trauma, stroke,&#xD;
             transient ischemic attacks&#xD;
&#xD;
          -  Musculoskeletal or mental illness&#xD;
&#xD;
          -  Addictive or previous addictive behavior defined as the abuse of cannabis, opioids or&#xD;
             other drugs&#xD;
&#xD;
          -  Inability to cooperate&#xD;
&#xD;
          -  Pregnancy or breastfeeding, including women trying to conceive&#xD;
&#xD;
          -  Use of vitamin D supplementation&gt; 10μg&#xD;
&#xD;
          -  In treatment with digoxin or thiazide&#xD;
&#xD;
          -  Patients with osteoarthritis, as they are taking or have taken vitamin D supplements&#xD;
&#xD;
          -  Patients with pre-existing hypercalcemia as vitamin D supplements are contraindicated&#xD;
             in these patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Parisa Gazerani, Pharm D, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Aalborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CCBR Aalborg A/S</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg University</name>
      <address>
        <city>Aalborg</city>
        <zip>9220</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>December 28, 2015</last_update_submitted>
  <last_update_submitted_qc>December 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Parisa Gazerani</investigator_full_name>
    <investigator_title>Associate Professor, Pharm D, PhD</investigator_title>
  </responsible_party>
  <keyword>Migraine</keyword>
  <keyword>Vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01695460
org study id: N-20120052
secondary id: Projekt #831302
nct id: NCT01695460
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The trial is primarily designed to investigate whether treatment with vitamin D may influence
      migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve
      as a prophylactic treatment of migraine. The hypothesis is tested by examining the changes in
      the pain and symptom patterns associated with migraine by treatment with Vitamin D, by means
      of quantitative sensory testing, diaries and blood samples for measurement of vitamin D.
      Other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in
      the blood is changed by the treatment with vitamin D. The hypothesis here is that levels of
      those biomarkers will change following the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The number of migraine attacks
time frame: every 4 weeks
description: The primary endpoint is the frequency of migraine attacks. This is estimated from the subjects' listing of attacks in the form of diaries. This is assessed as the number of migraine attacks per 4 weeks (28 days).
measure: Evaluation of pain during migraine attacks
time frame: every 4 weeks
description: Evaluation of pain during migraine attacks carried out by the subjects themselves by completing diaries. The diaries trial participants evaluate the pain intensity during an attack using a 1-3 scale, where 1 is mild pain, 2 is moderate pain, and 3 severe pain.
measure: Hypersensitivity
time frame: Baseline and every 4 weeks
description: allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.
measure: Migraine Symptoms
time frame: every 4 weeks
description: Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.
measure: Quantitative Sensory Testing
time frame: Every 4 weeks
description: Pain Pressure Threshold and temporal summation are measured.
measure: Measuring levels of a biomarker. Changes in the levels of these biomarkers.
time frame: Baseline and after 6 months treatment (end of trial)
description: Changes in the levels of these biomarkers are measured:
25(OH)D, 1,25(OH)D, GFAP, S100B, CGRP,Glutamate, Serotonin, Prostaglandin E2
measure: Quality of life
time frame: Every 28 days
description: HIT-6 (Headache Impact Test)
arm group label: Vitamin D
arm group type: Active Comparator
description: The active treatment consists of vitamin D and is given in tablets of the brand D3 Vitamin ®, supplied by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg.
The tablets contain the vitamin D in the form of vitamin D3, also known as cholecalciferol.
D3 Vitamin ® consists of small white tablets, which are easy to swallow.
D3 Vitamin ® contains 25 micrograms vitamin D3 (colecalciferol) per tablet, equivalent to 1000 IU (International Units).
Tablet Excipients: Cellulose, dicalcium phosphate, magnesium stearate, silicon dioxide and talc. Vitamin D3 ® contains no gluten, soy, gelatin or other animal products.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablets to match D3 Vitamin ®, were produced. They are identical to the D3 Vitamin ® in appearance, ie small white tablets. These tablets do not have a therapeutic effect. Placebo tablets produced and delivered by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg.
intervention type: Drug
intervention name: D3 Vitamin ®
description: Vitamin D and placebo supplied as tablets in containers of 124. The containers must be kept in dry and not too hot environment.
All subjects randomized to vitamin D, will receive 100 micrograms of vitamin D3/day, equivalent to 4000 IU. Vitamin D is administered orally 1 time a day with breakfast.
arm group label: Vitamin D
other name: D3 Vitamin ®, supplied by D3 Pharmacy Ltd
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
other name: Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Parisa Gazerani, Pharm D, PhD
role: Study Chair
affiliation: Aalborg University
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Parisa Gazerani
investigator title: Associate Professor, Pharm D, PhD
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Cholecalciferol
mesh term: Vitamins