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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695460
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : December 29, 2015
CCBR Aalborg A/S, Aalborg, Denmark
Aalborg University Hospital
Information provided by (Responsible Party):
Parisa Gazerani, Aalborg University

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.

Condition or disease Intervention/treatment Phase
Migraine According to International Headache Society (IHS) Criteria (ICHD-II) Drug: D3 Vitamin ® Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Study Start Date : September 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine Vitamin D

Arm Intervention/treatment
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.

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

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.
Drug: Placebo
Other Name: Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Migraine Symptoms [ Time Frame: every 4 weeks ]
    Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.

  4. Quantitative Sensory Testing [ Time Frame: Every 4 weeks ]
    Pain Pressure Threshold and temporal summation are measured.

  5. 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

Other Outcome Measures:
  1. Quality of life [ Time Frame: Every 28 days ]
    HIT-6 (Headache Impact Test)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695460

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CCBR Aalborg A/S
Aalborg, Denmark, 9000
Aalborg University
Aalborg, Denmark, 9220
Sponsors and Collaborators
Aalborg University
CCBR Aalborg A/S, Aalborg, Denmark
Aalborg University Hospital
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Study Chair: Parisa Gazerani, Pharm D, PhD Aalborg University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Parisa Gazerani, Associate Professor, Pharm D, PhD, Aalborg University Identifier: NCT01695460     History of Changes
Other Study ID Numbers: N-20120052
Projekt #831302 ( Other Grant/Funding Number: Det Frie Forskningsråd )
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Keywords provided by Parisa Gazerani, Aalborg University:
Vitamin D
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents