A multi-centre, randomised, double-blind, placebo controlled clinical trial examining the efficiency and safety of multi-vitamin therapy in secondary stroke prevention
| ISRCTN | ISRCTN74743444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74743444 |
| ClinicalTrials.gov (NCT) | NCT00097669 |
| Protocol serial number | G0200583 |
| Sponsor | University of Glasgow and Greater Glasgow Health Board (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 22/05/2003
- Registration date
- 22/05/2003
- Last edited
- 11/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kennedy R Lees
Scientific
Scientific
Department of Medicine & Therapeutics
Gardiner Institute
Western Infirmary
44 Church Street
Glasgow
G11 6NT
United Kingdom
| krl1r@clinmed.gla.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double-blind placebo-controlled clinical |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | VITATOPS |
| Study objectives | To determine whether the addition of vitamin supplement (folate 2 mg, B6 25 mg, B12 500 µg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infraction) and vascular death in patients with recent stroke or transient ischaemic attach (TIA). Secondary objectives: 1. To determine whether the addition of vitamin supplements (folate 2 mg, B6 25 mg, B12 500 µg) will reduce: a) The incidence of revascularisation procedures of the coronary, cerebral and peripheral circulations b) Incidence of dementia and depression in patient with recent stroke or TIA c) Occurrence of TIA in patients with recent stroke or TIA 2. To determine whether the effect of adding vitamin supplements (folate 2 mg, B6 25 mg, B12 500 µg) on the incidence of the primary outcome event (stroke, MI or vascular death) is consistent in patient subgroups such as those of different ethnicity and genotype. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular |
| Intervention | Multivitamins folate 2 mg, B6 25 mg, B12 500 µg or placebo |
| Intervention type | Supplement |
| Primary outcome measure(s) |
The primary outcome event is the composite event 'stroke, myocardial infarction, or death from any vascular cause', whichever occurs first. |
| Key secondary outcome measure(s) |
Secondary outcome measures include TIA, depression, dementia, unstable angina, revascularisation procedures of the coronary, cerebral and peripheral circulations. |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 8000 |
| Key inclusion criteria | All patients presenting to one of the participating neurologists or general physicians within 7 months of stroke (ischaemic or haemorrhagic) or transient ischemic attack (TIA) (eye or brain) are eligible for this trial. In addition the patient must: 1. Agree to take study medications 2. Be geographically accessible for follow up 3. Provide written informed consent |
| Key exclusion criteria | 1. Taking folate or vitamin B6, on medical advice 2. Use of vitamin supplements containing B6, B12 or Folate (unless patient agrees to take study medication instead of the vitamin supplements which they usually take) 3. Taking Methotrexate for any reason 4. Pregnancy or women of child-bearing potential who are at risk of pregnancy 5. Limited life expectancy |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
- Australia
- Austria
- Belgium
- Brazil
- Georgia
- Hong Kong
- India
- Italy
- Malaysia
- Moldova
- Netherlands
- New Zealand
- Pakistan
- Philippines
- Portugal
- Serbia
- Singapore
- Sri Lanka
- United States of America
Study participating centre
Department of Medicine & Therapeutics
Glasgow
G11 6NT
United Kingdom
G11 6NT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2010 | Yes | No | |
| Results article | cancer sub-study results | 01/06/2012 | Yes | No | |
| Results article | results | 01/06/2012 | Yes | No | |
| Results article | MRI sub-study results | 01/12/2012 | Yes | No | |
| Results article | osteoporotic fractures sub-study results | 03/09/2013 | Yes | No | |
| Protocol article | protocol | 01/04/2002 | Yes | No | |
| Other publications | secondary analysis | 01/08/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
