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.
Migraine According to International Headache Society (IHS) Criteria (ICHD-II)
Drug: D3 Vitamin ®
|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)
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Other Name: Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd
|Contact: Ali Karshenas, MDfirstname.lastname@example.org|
|Contact: Flemming W Bach, Overlæge, email@example.com|
|Aalborg, Denmark, 9220|
|Contact: Parisa Gazerani, PharmD, PhD +4599402412 firstname.lastname@example.org|
|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|