A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine According to International Headache Society (IHS) Criteria (ICHD-II) |
Drug: D3 Vitamin ® Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine |
- The number of migraine attacks [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]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).
- Evaluation of pain during migraine attacks [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: Baseline and every 4 weeks ] [ Designated as safety issue: Yes ]allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.
- Migraine Symptoms [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.
- Quantitative Sensory Testing [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]Pain Pressure Threshold and temporal summation are measured.
- Measuring levels of a biomarker. Changes in the levels of these biomarkers. [ Time Frame: Baseline and after 6 months treatment (end of trial) ] [ Designated as safety issue: Yes ]
Changes in the levels of these biomarkers are measured:
25(OH)D, 1,25(OH)D, GFAP, S100B, CGRP,Glutamate, Serotonin, Prostaglandin E2
- Quality of life [ Time Frame: Every 28 days ] [ Designated as safety issue: No ]HIT-6 (Headache Impact Test)
| Estimated Enrollment: | 48 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vitamin D
The active treatment consists of vitamin D and is given in tablets of the brand D3 Vitamin ®, supplied by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg. The tablets contain the vitamin D in the form of vitamin D3, also known as cholecalciferol. D3 Vitamin ® consists of small white tablets, which are easy to swallow. D3 Vitamin ® contains 25 micrograms vitamin D3 (colecalciferol) per tablet, equivalent to 1000 IU (International Units). Tablet Excipients: Cellulose, dicalcium phosphate, magnesium stearate, silicon dioxide and talc. Vitamin D3 ® contains no gluten, soy, gelatin or other animal products. |
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. Other Name: D3 Vitamin ®, supplied by D3 Pharmacy Ltd
|
|
Placebo Comparator: Placebo
Placebo tablets to match D3 Vitamin ®, were produced. They are identical to the D3 Vitamin ® in appearance, ie small white tablets. These tablets do not have a therapeutic effect. Placebo tablets produced and delivered by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg.
|
Drug: Placebo
Other Name: Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Ali Karshenas, MD | +4599328459 | ali.karshenas@rn.dk |
| Contact: Flemming W Bach, Overlæge, dr.med | +4599321928 | fwb@rn.dk |
| Denmark | |
| Aalborg University | Recruiting |
| Aalborg, Denmark, 9220 | |
| Contact: Parisa Gazerani, PharmD, PhD +4599402412 gazerani@hst.aau.dk | |
| Contact: Lars Arendt-Nielsen, dr. med. sci., PhD +4599408830 LAN@hst.aau.dk | |
| Principal Investigator: Parisa Gazerani, Pharm D, PhD | |
| Sub-Investigator: Randi Fuglsang, BSc, MSc | |
| Sub-Investigator: Jannie G Pedersen, BSc, MSc | |
| Sub-Investigator: Brian E Cairns, PhD | |
| CCBR Aalborg A/S | Recruiting |
| Aalborg, Denmark, 9000 | |
| Contact: Hans Christian Hoeck, Md, PhD +45 9633 4720 Hans.Hoeck@ccbr.com | |
| Contact: Michael W Boserup, MMedSci +4596334715 Michael.Boserup@ccbr.com | |
| Sub-Investigator: Morten R Sørensen, MMedSci | |
| Study Chair: | Parisa Gazerani, Pharm D, PhD | Aalborg University |
More Information
No publications provided
| Responsible Party: | Parisa Gazerani, Associate Professor, Pharm D, PhD, Aalborg University |
| ClinicalTrials.gov Identifier: | NCT01695460 History of Changes |
| Other Study ID Numbers: | N-20120052, Projekt #831302 |
| Study First Received: | September 25, 2012 |
| Last Updated: | September 26, 2012 |
| Health Authority: | Denmark: Den Videnskabsetiske Komité for Region Nordjylland |
Keywords provided by Aalborg University:
|
Migraine Vitamin D |
Additional relevant MeSH terms:
|
Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013