Clinical trial NCT01695460: A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Official title: A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine According to International Headache Society (IHS) Criteria (ICHD-II)
Keywords: Migraine
Vitamin D
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: CCBR Aalborg A/S, Aalborg, Denmark
name: Aalborg University Hospital
First posted: 2012-09-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of migraine attacks
timeFrame: every 4 weeks
Secondary outcomes:
measure: Evaluation of pain during migraine attacks
timeFrame: every 4 weeks
measure: Hypersensitivity
timeFrame: Baseline and every 4 weeks
measure: Migraine Symptoms
timeFrame: every 4 weeks
measure: Quantitative Sensory Testing
timeFrame: Every 4 weeks
measure: Measuring levels of a biomarker. Changes in the levels of these biomarkers.
timeFrame: Baseline and after 6 months treatment (end of trial)
Other outcomes:
measure: Quality of life
timeFrame: Every 28 days
Locations:
city: Aalborg
country: Denmark
facility: CCBR Aalborg A/S
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Parisa Gazerani, Pharm D, PhD
role: STUDY_CHAIR
References:
citation: Gazerani P, Fuglsang R, Pedersen JG, Sorensen J, Kjeldsen JL, Yassin H, Nedergaard BS. A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D3 supplementation in adult patients with migraine. Curr Med Res Opin. 2019 Apr;35(4):715-723. doi: 10.1080/03007995.2018.1519503. Epub 2018 Sep 28.