None listed
Conditions
Brief summary
This study aims to determine whether vitamin therapy is an effective complementary or alternative therapy for reducing migraine disability, and whether nutritional supplementation targeted to a gene specific mutation associated with migraine is proven to be effective
Interventions
12 months’ treatment with either B vitamins (25mg pyridoxine hydrochloride (HCl), folic acid 2mg, and vitamin B12 400mcg) or a placebo. Intervention dose: One trial tablet (B vitamin or Placebo) taken once daily for 12 months. Mode of administration: Oral tablet.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed