Welcome
Support Centre
17 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
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 10.1186/ISRCTN74743444
ClinicalTrials.gov identifier NCT00097669
EudraCT number
Public title A multi-centre, randomised, double-blind, placebo controlled clinical trial examining the efficiency and safety of multi-vitamin therapy in secondary stroke prevention
Scientific title
Acronym VITATOPS
Serial number at source G0200583
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Multicentre randomised double-blind placebo controlled clinical
Countries of recruitment United Kingdom, International
Disease/condition/study domain Cardiovascular
Participants - 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
Participants - 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
Anticipated start date 01/07/2003
Anticipated end date 31/07/2010
Status of trial Completed
Patient information material http://vitatops.highway1.com.au/html/index.asp?section=gen
Target number of participants 8000 Added 07/07/09: UK sample size is 1000 patients.
Interventions Multivitamins folate 2 mg, B6 25 mg, B12 500 µg or placebo
Primary outcome measure(s) The primary outcome event is the composite event 'stroke, myocardial infarction, or death from any vascular cause', whichever occurs first.
Secondary outcome measure(s) Secondary outcome measures include TIA, depression, dementia, unstable angina, revascularisation procedures of the coronary, cerebral and peripheral circulations.
Sources of funding Medical Research Council (MRC) (UK)
Trial website http://vitatops.highway1.com.au/index.htm
Publications 1. 2002 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/11867886
2. 2010 results in : http://www.ncbi.nlm.nih.gov/pubmed/20688574
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22554931
4. 2012 cancer sub-study results in http://www.ncbi.nlm.nih.gov/pubmed/22474057
5. 2012 MRI sub-study results in http://www.ncbi.nlm.nih.gov/pubmed/23093615
6. 2013 osteoporotic fractures sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/24004645
7. 2013 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/23765945
Contact name Prof  Kennedy R  Lees
  Address Department of Medicine & Therapeutics
Gardiner Institute
Western Infirmary
44 Church Street
  City/town Glasgow
  Zip/Postcode G11 6NT
  Country United Kingdom
  Email krl1r@clinmed.gla.ac.uk
Sponsor University of Glasgow and Greater Glasgow Health Board (UK)
  Address University of Glasgow
  City/town Glasgow
  Zip/Postcode G12 8QQ
  Country United Kingdom
  Tel +44 (0)141 330 2000
  Email
  Sponsor website: http://www.gla.ac.uk/
Date applied 22/05/2003
Last edited 27/09/2013
Date ISRCTN assigned 22/05/2003
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.