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 number	NCT00097669
Secondary identifying numbers	G0200583

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

Not provided at time of registration

Study website

Contact information

Prof Kennedy R Lees
Scientific

Department of Medicine & Therapeutics
Gardiner Institute
Western Infirmary
44 Church Street
Glasgow
G11 6NT
United Kingdom

Email	krl1r@clinmed.gla.ac.uk

Study information

Study design	Multicentre randomised double-blind placebo-controlled clinical
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Patient information can be found at: http://vitatops.highway1.com.au/html/index.asp?section=gen
Scientific title
Study acronym	VITATOPS
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.
Ethics approval(s)	Not provided at time of registration
Condition	Cardiovascular
Intervention	Multivitamins folate 2 mg, B6 25 mg, B12 500 µg or placebo
Intervention type	Supplement
Primary outcome measure	The primary outcome event is the composite event 'stroke, myocardial infarction, or death from any vascular cause', whichever occurs first.
Secondary outcome measures	Secondary outcome measures include TIA, depression, dementia, unstable angina, revascularisation procedures of the coronary, cerebral and peripheral circulations.
Overall study start date	01/07/2003
Overall study end date	31/07/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	8000 Added 07/07/2009: UK sample size is 1000 patients.
Participant 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
Participant 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
Recruitment start date	01/07/2003
Recruitment end date	31/07/2010

Locations

Countries of recruitment

Australia
Austria
Belgium
Brazil
Georgia
Hong Kong
India
Italy
Malaysia
Moldova
Netherlands
New Zealand
Pakistan
Philippines
Portugal
Scotland
Serbia
Singapore
Sri Lanka
United Kingdom
United States of America

Study participating centre

Department of Medicine & Therapeutics

Glasgow
G11 6NT
United Kingdom

Sponsor information

University of Glasgow and Greater Glasgow Health Board (UK)
Not defined

University of Glasgow
Glasgow
G12 8QQ
United Kingdom

Phone	+44 (0)141 330 2000
Website	http://www.gla.ac.uk/
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/04/2002	Yes	No
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
Other publications	secondary analysis	01/08/2013	Yes	No
Results article	osteoporotic fractures sub-study results	03/09/2013	Yes	No