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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Aalborg University
Sponsor:
Collaborators:
CCBR Aalborg A/S, Aalborg, Denmark
Aalborg Universityhospital
Information provided by (Responsible Party):
Parisa Gazerani, Aalborg University
ClinicalTrials.gov Identifier:
NCT01695460
First received: September 25, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine

Resource links provided by NLM:


Further study details as provided by Aalborg University:

Primary Outcome Measures:
  • The number of migraine attacks [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Evaluation of pain during migraine attacks [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.

  • Migraine Symptoms [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]

    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:
  • Quality of life [ Time Frame: Every 28 days ] [ Designated as safety issue: No ]
    HIT-6 (Headache Impact Test)


Estimated Enrollment: 48
Study Start Date: September 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695460

Contacts
Contact: Ali Karshenas, MD +4599328459 ali.karshenas@rn.dk
Contact: Flemming W Bach, Overlæge, dr.med +4599321928 fwb@rn.dk

Locations
Denmark
Aalborg University Recruiting
Aalborg, Denmark, 9220
Contact: Parisa Gazerani, PharmD, PhD    +4599402412    gazerani@hst.aau.dk   
Contact: Lars Arendt-Nielsen, dr. med. sci., PhD    +4599408830    LAN@hst.aau.dk   
Principal Investigator: Parisa Gazerani, Pharm D, PhD         
Sub-Investigator: Randi Fuglsang, BSc, MSc         
Sub-Investigator: Jannie G Pedersen, BSc, MSc         
Sub-Investigator: Brian E Cairns, PhD         
CCBR Aalborg A/S Recruiting
Aalborg, Denmark, 9000
Contact: Hans Christian Hoeck, Md, PhD    +45 9633 4720    Hans.Hoeck@ccbr.com   
Contact: Michael W Boserup, MMedSci    +4596334715    Michael.Boserup@ccbr.com   
Sub-Investigator: Morten R Sørensen, MMedSci         
Sponsors and Collaborators
Aalborg University
CCBR Aalborg A/S, Aalborg, Denmark
Aalborg Universityhospital
Investigators
Study Chair: Parisa Gazerani, Pharm D, PhD Aalborg University
  More Information

No publications provided

Responsible Party: Parisa Gazerani, Associate Professor, Pharm D, PhD, Aalborg University
ClinicalTrials.gov Identifier: NCT01695460     History of Changes
Other Study ID Numbers: N-20120052, Projekt #831302
Study First Received: September 25, 2012
Last Updated: September 26, 2012
Health Authority: Denmark: Den Videnskabsetiske Komité for Region Nordjylland

Keywords provided by Aalborg University:
Migraine
Vitamin D

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014