VITATOPS - a controlled trial of vitamins to prevent stroke

VITATOPS study - A randomised, double-blind, placebo-controlled trial of vitamins to prevent stroke

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000005651

Acronym

VITATOPS

Enrollment

8164

Registered

2005-07-13

Start date

1998-11-19

Completion date

2008-12-31

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Healthy volunteers

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.

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.

Outcome results