A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
NCT ID: NCT01695460
Last Updated: 2015-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2012-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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.
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.
Placebo
Interventions
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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.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed migraine according to International Headache Society (IHS) criteria (ICHD-II)
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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CCBR Aalborg A/S, Aalborg, Denmark
UNKNOWN
Aalborg University Hospital
OTHER
Aalborg University
OTHER
Responsible Party
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Parisa Gazerani
Associate Professor, Pharm D, PhD
Principal Investigators
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Parisa Gazerani, Pharm D, PhD
Role: STUDY_CHAIR
Aalborg University
Locations
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CCBR Aalborg A/S
Aalborg, , Denmark
Aalborg University
Aalborg, , Denmark
Countries
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References
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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.
Other Identifiers
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Projekt #831302
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
N-20120052
Identifier Type: -
Identifier Source: org_study_id