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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
48
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.
CCBR Aalborg A/S
Aalborg, Denmark
Aalborg University
Aalborg, Denmark
The number of migraine attacks
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).
Time frame: every 4 weeks
Evaluation of pain during migraine attacks
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.
Time frame: every 4 weeks
Hypersensitivity
allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.
Time frame: Baseline and every 4 weeks
Migraine Symptoms
Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.
Time frame: every 4 weeks
Quantitative Sensory Testing
Pain Pressure Threshold and temporal summation are measured.
Time frame: Every 4 weeks
Measuring levels of a biomarker. Changes in the levels of these biomarkers.
Changes in the levels of these biomarkers are measured: 25(OH)D, 1,25(OH)D, GFAP, S100B, CGRP,Glutamate, Serotonin, Prostaglandin E2
Time frame: Baseline and after 6 months treatment (end of trial)
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