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

NCT01695460 | Completed Phase 3 DMC

• 2 other identifiers: N-20120052Projekt #831302
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Migraine; Vitamin D

Outcome Measures

Primary Outcomes (1)

• The number of migraine attacks

  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).

  every 4 weeks

Secondary Outcomes (5)

• Evaluation of pain during migraine attacks

  every 4 weeks

• Hypersensitivity

  Baseline and every 4 weeks

• Migraine Symptoms

  every 4 weeks

• Quantitative Sensory Testing

  Every 4 weeks

• Measuring levels of a biomarker. Changes in the levels of these biomarkers.

  Baseline and after 6 months treatment (end of trial)

Other Outcomes (1)

• Quality of life

  Every 28 days

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

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 ®

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

D3 Vitamin ® DRUG

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.

Also known as: D3 Vitamin ®, supplied by D3 Pharmacy Ltd

Vitamin D

Placebo DRUG

Also known as: Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead
• CCBR Aalborg A/S, Aalborg, Denmark: collaborator
• Aalborg University Hospital: collaborator

Study Sites (2)

CCBR Aalborg A/S

Aalborg, 9000, Denmark

Location

Aalborg University

Aalborg, 9220, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30182753 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Parisa Gazerani, Pharm D, PhD

  Aalborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pharm D, PhD

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 28, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

DK (2)