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A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine

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ClinicalTrials.gov Identifier: NCT01695460
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : December 29, 2015
Sponsor:
Collaborators:
CCBR Aalborg A/S, Aalborg, Denmark
Aalborg University Hospital
Information provided by (Responsible Party):
Parisa Gazerani, Aalborg University

Tracking Information
First Submitted Date  ICMJE September 25, 2012
First Posted Date  ICMJE September 28, 2012
Last Update Posted Date December 29, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
The number of migraine attacks [ Time Frame: every 4 weeks ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01695460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
  • Evaluation of pain during migraine attacks [ Time Frame: every 4 weeks ]
    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.
  • Hypersensitivity [ Time Frame: Baseline and every 4 weeks ]
    allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.
  • Migraine Symptoms [ Time Frame: every 4 weeks ]
    Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.
  • Quantitative Sensory Testing [ Time Frame: Every 4 weeks ]
    Pain Pressure Threshold and temporal summation are measured.
  • Measuring levels of a biomarker. Changes in the levels of these biomarkers. [ Time Frame: Baseline and after 6 months treatment (end of trial) ]
    Changes in the levels of these biomarkers are measured: 25(OH)D, 1,25(OH)D, GFAP, S100B, CGRP,Glutamate, Serotonin, Prostaglandin E2
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 26, 2012)
Quality of life [ Time Frame: Every 28 days ]
HIT-6 (Headache Impact Test)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Official Title  ICMJE A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Migraine According to International Headache Society (IHS) Criteria (ICHD-II)
Intervention  ICMJE
  • Drug: D3 Vitamin ®

    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.

    Other Name: D3 Vitamin ®, supplied by D3 Pharmacy Ltd
  • Drug: Placebo
    Other Name: Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd
Study Arms  ICMJE
  • Active Comparator: Vitamin D

    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.

    Intervention: Drug: D3 Vitamin ®
  • Placebo Comparator: Placebo
    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: Drug: Placebo
Publications * Gazerani P, Fuglsang R, Pedersen JG, Sørensen J, Kjeldsen JL, Yassin H, Nedergaard BS. A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D(3) supplementation in adult patients with migraine. Curr Med Res Opin. 2019 Apr;35(4):715-723. doi: 10.1080/03007995.2018.1519503. Epub 2018 Sep 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2012)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women between 18 and 65, migraine must have occurred before the age of 50 years.
  • Diagnosed migraine according to International Headache Society (IHS) criteria (ICHD-II)

Exclusion Criteria:

  • Other neurological or neurodegenerative disorders
  • Medical conditions that may interfere with the result - violent head trauma, stroke, transient ischemic attacks
  • Musculoskeletal or mental illness
  • Addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs
  • Inability to cooperate
  • Pregnancy or breastfeeding, including women trying to conceive
  • Use of vitamin D supplementation> 10μg
  • In treatment with digoxin or thiazide
  • Patients with osteoarthritis, as they are taking or have taken vitamin D supplements
  • Patients with pre-existing hypercalcemia as vitamin D supplements are contraindicated in these patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01695460
Other Study ID Numbers  ICMJE N-20120052
Projekt #831302 ( Other Grant/Funding Number: Det Frie Forskningsråd )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Parisa Gazerani, Aalborg University
Study Sponsor  ICMJE Aalborg University
Collaborators  ICMJE
  • CCBR Aalborg A/S, Aalborg, Denmark
  • Aalborg University Hospital
Investigators  ICMJE
Study Chair: Parisa Gazerani, Pharm D, PhD Aalborg University
PRS Account Aalborg University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP