Condition category
Nervous System Diseases
Date applied
29/11/2007
Date assigned
18/12/2007
Last edited
18/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes