A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine

Aalborg University

Status and phase: Completed; Phase 3

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

Treatments: Drug: D3 Vitamin ®; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01695460

N-20120052

Projekt #831302 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Vitamin D

Active Comparator group

Description:

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.

Treatment:

Drug: D3 Vitamin ®

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo