Contact information
Type
Scientific
Primary contact
Prof Lyn Griffiths
ORCID ID
Contact details
Griffith University
Gold Coast campus
Gold Coast
9726
Australia
L.Griffiths@griffith.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Does vitamin therapy including folic acid reduce homocysteine and migraine disability, and is the effect dependent on MTHFR genotype?
Ethics approval
The study was approved by the Griffith University Ethics Committee on 11 November 2005 (ref: 3425)
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Migraine with aura
Intervention
Daily B vitamin (B6, B9, B12) therapy vs placebo for 6 months
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Migraine disability, as measured using the Migraine Disability Assessment (MIDAS) score at baseline and 6 months.
Secondary outcome measures
1. Migraine frequency. Duration of follow-up: 6 months
2. Migraine pain: MIDAS pain score 1-10 (10 = most severe) at baseline and 6 months
Overall trial start date
30/11/2006
Overall trial end date
30/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Current diagnosis of regular migraine with aura attacks
2. >18 and <70 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Co-morbid vascular or neuropsychiatric disease
2. Pregnant
3. Currently taking B vitamins
Recruitment start date
30/11/2006
Recruitment end date
30/11/2007
Locations
Countries of recruitment
Australia
Trial participating centre
Griffith University
Gold Coast
9726
Australia
Sponsor information
Organisation
Griffith University (Australia)
Sponsor details
c/o Prof Lyn Griffiths
Gold Coast campus
Griffith University Qld 4222
Gold Coast
9726
Australia
L.Griffiths@griffith.edu.au
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Brain Foundation of Australia
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary