The effect of vitamin supplementation, genotype and homocysteine on migraine frequency and severity in females diagnosed with migraine with aura.
- Conditions
- Migraine with auraAlternative and Complementary Medicine - Other alternative and complementary medicineNeurological - Other neurological disorders
- Registration Number
- ACTRN12609000275268
- Lead Sponsor
- Griffith University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 250
Female aged 18 to 65 years of age.
Have a diagnosis of migraine with aura (MA) according to International Headache Society Criteria.
Unrelated by first degree - we hypothesise that our outcome variable, response to vitamin therapy, is influenced by inherited factors, so genetic independence of participants is important.
Suffer at least 4 migraine episodes per year.
Of Caucasian ancestral background.
Participants with adequate venous access in their left and right arms to allow collection of a number of blood samples via venepuncture.
Fluent in the English language.
Have voluntarily given written informed consent to participate in this study.
Be able to attend the Genomics Research Centre (GRC) clinical trials facility on the Gold Coast.
Participated in the migraine-vitamin trial pilot study.
Has a clinically recognised co-morbid disease e.g. vascular disease, depression, epilepsy.
Other severe illness that might interfere with assessment or hamper patient’s ability to complete the study e.g. compliance.
Pregnancy or planned pregnancy in the study period.
History of any psychiatric illness.
Inability to comply with treatment regime or attend clinic assessments.
Participation in another clinical trial or received experimental therapy within last 30 days.
Donated or lost a significant amount of blood (e.g. 550 mL) within the past 12 weeks.
Persons already taking vitamin B and/or folic acid supplementation.
Persons who have ever been diagnosed with cancer.
Persons who have three or more first degree relatives who have been diagnosed with cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of vitamin supplementation in migraine patients we will measure the 12-month retrospective migraine disability using the Migraine Disability Assessment Score (MIDAS) - a measure of migraine impact on quality of life. This post-treatment score will be compared to the baseline MIDAS score to establish the primary outcome variable (i.e. change in MIDAS score).[At zero year and at one year after randomisation.]
- Secondary Outcome Measures
Name Time Method Change in plasma homocysteine and vitamin levels will be assessed through a National Association of Testing Authorities (NATA) accredited laboratory using B6 plasma assay and homocysteine, folic acid and B12 serum assays.[At zero year and at one year after randomisation.]