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

December 28, 2015 updated by: Parisa Gazerani, Aalborg University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9220
        • Aalborg University
      • Aalborg, Denmark, 9000
        • CCBR Aalborg A/S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
every 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 4 weeks
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.
Baseline and every 4 weeks
Migraine Symptoms
Time Frame: every 4 weeks
Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.
every 4 weeks
Quantitative Sensory Testing
Time Frame: Every 4 weeks
Pain Pressure Threshold and temporal summation are measured.
Every 4 weeks
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
Baseline and after 6 months treatment (end of trial)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Every 28 days
HIT-6 (Headache Impact Test)
Every 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Collaborators

Aalborg University Hospital
CCBR Aalborg A/S, Aalborg, Denmark

Investigators

  • Study Chair: Parisa Gazerani, Pharm D, PhD, Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (ESTIMATE)

September 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20120052
  • Projekt #831302 (OTHER_GRANT: Det Frie Forskningsråd)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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