Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000005651
Ethics application status
Approved
Date submitted
13/07/2005
Date registered
13/07/2005
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Date results information initially provided
10/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
VITATOPS - a controlled trial of vitamins to prevent stroke
Scientific title
VITATOPS study - A randomised, double-blind, placebo-controlled trial of vitamins to prevent stroke
Universal Trial Number (UTN)
Trial acronym
VITATOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 67 0
Condition category
Condition code
Stroke 79 79 0 0
Ischaemic
Stroke 2359 2359 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The VITATOPS trial is a randomised double-blind, placebo-controlled, multicentre trial. The study is testing the hypothesis that a high total plasma homocysteine concentration (tHcy) is a causal and modifiable risk factor for stroke which can be reduced by B-vitamin (folic acid, vitaminB6 and B12) supplementation. In this trial, patients are randomised to take a single tablet, once daily, containing either a placebo or a combination of folic acid 2mg, vitamin B6 25mg and vitamin B12 0.5mg.
Intervention code [1] 17 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 111 0
The combined incidence of recurrent non-fatal serious vascular events (stroke and myocardial infarction) and death due to vascular causes in a wide variety of patients with recent stroke or TIA from different countries around the world.
Timepoint [1] 111 0
in real time
Secondary outcome [1] 249 0
To determine whether the effect of these vitamin supplements on the primary outcome measure is consistent among the following subgroups of patients: patients of different race, genotype, and pathological and aetiological subtype of stroke; and outcome events: revascularisation procedures, TIA, depression, and dementia.
Timepoint [1] 249 0
in real time

Eligibility
Key inclusion criteria
All patients presenting within seven months of stroke (ischaemic or haemorrhagic) or TIA (eye or brain) are eligible. In addition, the patient must: agree to take study medications, be geographically accessible for follow-up and provide written informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking folic acid or vitamin B6 on medical advice, taking methotrexate for any reason, pregnancy or women of child-bearing potential who are at risk of pregnancy and limited life expectancy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation is by means of a central 24-hour telephone service or via an interactive website.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of patients to study groups involved random permuted blocks stratified by hospital. The random numbers were computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/11/1998
Actual
19/11/1998
Date of last participant enrolment
Anticipated
Actual
31/12/2008
Date of last data collection
Anticipated
Actual
23/06/2009
Sample size
Target
8000
Accrual to date
Final
8164
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 106 0
Austria
State/province [1] 106 0
Country [2] 107 0
Belgium
State/province [2] 107 0
Country [3] 108 0
Brazil
State/province [3] 108 0
Country [4] 109 0
Hong Kong
State/province [4] 109 0
Country [5] 110 0
India
State/province [5] 110 0
Country [6] 111 0
Italy
State/province [6] 111 0
Country [7] 112 0
Malaysia
State/province [7] 112 0
Country [8] 113 0
Moldova, Republic Of
State/province [8] 113 0
Country [9] 114 0
New Zealand
State/province [9] 114 0
Country [10] 115 0
Pakistan
State/province [10] 115 0
Country [11] 116 0
Philippines
State/province [11] 116 0
Country [12] 117 0
Portugal
State/province [12] 117 0
Country [13] 118 0
Georgia
State/province [13] 118 0
Country [14] 119 0
Serbia and Montenegro
State/province [14] 119 0
Country [15] 120 0
Singapore
State/province [15] 120 0
Country [16] 121 0
Sri Lanka
State/province [16] 121 0
Country [17] 122 0
United Kingdom
State/province [17] 122 0
Country [18] 123 0
United States of America
State/province [18] 123 0

Funding & Sponsors
Funding source category [1] 113 0
Government body
Name [1] 113 0
National Health & Medical Research Council
Country [1] 113 0
Australia
Funding source category [2] 114 0
Charities/Societies/Foundations
Name [2] 114 0
National Heart Foundation
Country [2] 114 0
Australia
Funding source category [3] 115 0
Government body
Name [3] 115 0
Health Department of Western Australia
Country [3] 115 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Level 5, 20 Allara Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 84 0
Government body
Name [1] 84 0
National Heart Foundation
Address [1] 84 0
334 Rokeby Road
Subiaco WA 6008
Country [1] 84 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308724 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 308724 0
Royal Perth Hospital
Wellington Street
Perth, Western Australia
6001
Ethics committee country [1] 308724 0
Australia
Date submitted for ethics approval [1] 308724 0
Approval date [1] 308724 0
14/04/1998
Ethics approval number [1] 308724 0
EC550

Summary
Brief summary
The VITATOPS study is an international multi-centre, randomised, double-blind, placebo-controlled, clinical trial designed primarily to examine the efficacy and safety of multi-vitamin (folate, B6, B12) therapy in the prevention of ‘stroke, myocardial infarction, or death from any vascular cause’, among patients randomised within seven months of a stroke or transient ischaemic attack (TIA) of the eye or brain. Secondary outcomes include TIA, dementia, depression unstable angina and revascularization procedures of the coronary, cerebral and peripheral circulations. It is planned that 8,000 patients will be randomised and followed up for a mean period of 2.5 years (range 1-8 years) by the end of 2009.
Trial website
[email protected]
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35450 0
Prof Graeme Hankey
Address 35450 0
Stroke Unit
Royal Perth Hospital
Wellington Street
Perth, Western Australia
6001
Country 35450 0
Australia
Phone 35450 0
+61 089224 7004
Fax 35450 0
Email 35450 0
[email protected]
Contact person for public queries
Name 9206 0
Miss Ms Julia Pizzi
Address 9206 0
Stroke Unit - Research Office
GPO Box X2213
Perth WA 6847
Country 9206 0
Australia
Phone 9206 0
+61 8 92247004
Fax 9206 0
+61 8 92248424
Email 9206 0
[email protected]
Contact person for scientific queries
Name 134 0
Miss Ms Julia Pizzi
Address 134 0
Stroke Unit - Research Office
GPO Box X2213
Perth WA 6847
Country 134 0
Australia
Phone 134 0
+61 8 92247004
Fax 134 0
+61 8 92248424
Email 134 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes B vitamins in patients with recent transient ischa... [More Details]

Documents added automatically
No additional documents have been identified.