The effects of homocysteine-lowering vitamin supplementation on migraine disability
| ISRCTN | ISRCTN34931928 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34931928 |
| Protocol serial number | N/A |
| Sponsor | Griffith University (Australia) |
| Funder | Brain Foundation of Australia |
- 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
Scientific
Griffith University
Gold Coast campus
Gold Coast
9726
Australia
| L.Griffiths@griffith.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does 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) studied | Migraine with aura |
| Intervention | Daily B vitamin (B6, B9, B12) therapy vs placebo for 6 months |
| Intervention type | Other |
| Primary outcome measure(s) |
Migraine disability, as measured using the Migraine Disability Assessment (MIDAS) score at baseline and 6 months. |
| Key secondary outcome measure(s) |
1. Migraine frequency. Duration of follow-up: 6 months |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Current diagnosis of regular migraine with aura attacks 2. >18 and <70 years old |
| Key exclusion criteria | 1. Co-morbid vascular or neuropsychiatric disease 2. Pregnant 3. Currently taking B vitamins |
| Date of first enrolment | 30/11/2006 |
| Date of final enrolment | 30/11/2007 |
Locations
Countries of recruitment
- Australia
Study participating centre
Griffith University
Gold Coast
9726
Australia
9726
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
