NCT01695460

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine According to International Headache Society (IHS) Criteria (ICHD-II)

Interventions

Type	Name	Description
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.
DRUG	Placebo

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-09-28
• Last updated: 2015-12-29

Locations

2 sites across 1 country: Denmark