Migraine According to International Headache Society (IHS) Criteria (ICHD-II) Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aalborg University | Aalborg | |
| Denmark | CCBR Aalborg A/S | Aalborg |
| Lead Sponsor | Collaborator |
|---|---|
| Aalborg University | Aalborg Universitetshospital, CCBR Aalborg A/S, Aalborg, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Quality of life | HIT-6 (Headache Impact Test) | Every 28 days | No |
| Primary | 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). | every 4 weeks | Yes |
| Secondary | 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. | every 4 weeks | Yes |
| Secondary | Hypersensitivity | allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine. | Baseline and every 4 weeks | Yes |
| Secondary | Migraine Symptoms | Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries. | every 4 weeks | Yes |
| Secondary | Quantitative Sensory Testing | Pain Pressure Threshold and temporal summation are measured. | Every 4 weeks | Yes |
| Secondary | 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 |
Baseline and after 6 months treatment (end of trial) | Yes |