The effects of homocysteine-lowering vitamin supplementation on migraine disability

ISRCTN ISRCTN34931928
DOI https://doi.org/10.1186/ISRCTN34931928
Secondary identifying numbers N/A
Submission date
29/11/2007
Registration date
18/12/2007
Last edited
18/12/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Lyn Griffiths
Scientific

Griffith University
Gold Coast campus
Gold Coast
9726
Australia

Email L.Griffiths@griffith.edu.au

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesDoes vitamin therapy including folic acid reduce homocysteine and migraine disability, and is the effect dependent on MTHFR genotype?
Ethics approval(s)The study was approved by the Griffith University Ethics Committee on 11 November 2005 (ref: 3425)
Health condition(s) or problem(s) studiedMigraine with aura
InterventionDaily B vitamin (B6, B9, B12) therapy vs placebo for 6 months
Intervention typeOther
Primary outcome measureMigraine disability, as measured using the Migraine Disability Assessment (MIDAS) score at baseline and 6 months.
Secondary outcome measures1. 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 study start date30/11/2006
Completion date30/11/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. Current diagnosis of regular migraine with aura attacks
2. >18 and <70 years old
Key exclusion criteria1. Co-morbid vascular or neuropsychiatric disease
2. Pregnant
3. Currently taking B vitamins
Date of first enrolment30/11/2006
Date of final enrolment30/11/2007

Locations

Countries of recruitment

  • Australia

Study participating centre

Griffith University
Gold Coast
9726
Australia

Sponsor information

Griffith University (Australia)
University/education

c/o Prof Lyn Griffiths
Gold Coast campus
Griffith University Qld 4222
Gold Coast
9726
Australia

Email L.Griffiths@griffith.edu.au
ROR logo "ROR" https://ror.org/02sc3r913

Funders

Funder type

Research organisation

Brain Foundation of Australia

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan