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

NCT01695460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-12-29

No results posted yet for this study

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)

Interventions

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

Sponsors & Collaborators

  • CCBR Aalborg A/S, Aalborg, Denmark

    collaborator UNKNOWN

  • Aalborg University Hospital

    collaborator OTHER

  • Aalborg University

    lead OTHER

Principal Investigators

  • Parisa Gazerani, Pharm D, PhD · Aalborg University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01695460 on ClinicalTrials.gov