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Completed

NCT Number: NCT01695460

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

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.

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Key information

Conditions

Migraine According to International Headache Society (IHS) Criteria (ICHD-II) Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aalborg University, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D3 Vitamin ®

Drug

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

Drug

Other names: Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd

Primary outcomes

  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 outcomes

  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 outcomes

  1. Quality of life

    Time frame: Every 28 days

    HIT-6 (Headache Impact Test)

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

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

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 28, 2012
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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