Migraine According to International Headache Society (IHS) Criteria (ICHD-II)
Conditions
Keywords
Migraine, Vitamin D
Brief 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.
Interventions
DRUGD3 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.
DRUGPlacebo
Sponsors
CCBR Aalborg A/S, Aalborg, Denmark
Aalborg University Hospital
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of migraine attacks | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pain during migraine attacks | 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. |
| Hypersensitivity | Baseline and every 4 weeks | allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine. |
| Quantitative Sensory Testing | Every 4 weeks | Pain Pressure Threshold and temporal summation are measured. |
| Measuring levels of a biomarker. Changes in the levels of these biomarkers. | 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 |
| Migraine Symptoms | every 4 weeks | Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Every 28 days | HIT-6 (Headache Impact Test) |
Countries
Denmark
Outcome results
None listed