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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aalborg University
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital; CCBR Aalborg A/S, Aalborg, Denmark
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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