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Migraine According to International Headache Society (IHS) Criteria (ICHD-II) | A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine

Migraine According to International Headache Society (IHS) Criteria (ICHD-II) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Migraine According to International Headache Society (IHS) Criteria (ICHD-II)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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.

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Vitamin DThe 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.

PlaceboPlacebo 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.

Study Status

Completed

Start Date: September 2012

Completed Date: December 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: The number of migraine attacks

Secondary Outcome: Evaluation of pain during migraine attacks

Study sponsors, principal investigator, and references

Principal Investigator: Parisa Gazerani, Pharm D, PhD

Lead Sponsor: Aalborg University

Collaborator: CCBR Aalborg A/S, Aalborg, Denmark

More information:https://clinicaltrials.gov/show/NCT01695460

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