None listed
Conditions
Brief summary
This trial intends to determine whether the use of vitamin B can be used as an effective treatment for migraine. This trial will compare the migraine outcomes in those taking low or high doses of the vitamins versus people taking mock medication.
Interventions
B group vitamins by daily oral pill. Treatment will continue for six months.
Arm 1: Vitamin B6 (25mg/day), Vitamin B12 (400mcg/day), Folate (2mg/day).
Arm 2: Vitamin B6 (12.5mg/day), Vitamin B12 (400mcg/day), Folate (1mg/day).
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
18 to 65 years of age. Male or female. Have a diagnosis of migraine with aura according to International Headache Society Criteria 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.
Exclusion criteria
Other definable cause for clinical presentation (i.e. not migraine). Other severe illness or use of medication that might interfere with assessment or hamper patients ability to complete the study. Pregnancy History of any psychiatric illness which may impair the ability to provide written informed consent. Poor compliers or those unlikely to attend. Participation in a clinical trial, or has received any experimental therapy, within the 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 supplementation
Outcome results
None listed