VITATOPS - a randomised controlled trial of vitamins to prevent stroke

Funded Activity Summary

A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS study arises from a large body of consistent, biologically plausible evidence linking homocysteine in a dose-dependent fashion to stroke and other types of vascular disease. A simple, non-toxic, and inexpensive intervention in the form of multivitamins (folate, B6 and B12) has been shown to be highly effective at reducing homocysteine levels, irrespective of the underlying cause. All patients who are referred to a neurologist or general physician in one of the collaborating centres within six months of a stroke or transient ischaemic attack are eligible for the trial. In total, treatment will continue for a period of between 1 and 5 years. During this time, patients will be closely monitored in order to record the occurrence of any vascular events (particularly strokes and heart attacks). Neither the study investigator nor the patient will know which treatment they are receiving (i.e. it is 'double blind'). The number of vascular events in the treatment groups will be compared at the end of the study in order to determine whether vitamin treatment is beneficial. This application is for five years of support to allow the investigators to move from the pilot phase of VITATOPS in Perth to begin recruitment to the definitive trial in other centres across Australia and New Zealand. This study may have a major impact on patient management. If vitamins prove to be effective, we may recommend vitamin supplementation to all of our stroke patients in the future.

Funded Activity Details

Start Date: 01-01-2000

End Date: 01-01-2002

Funding Scheme: NHMRC Project Grants

Funding Amount: $391,364.00

Funder: National Health and Medical Research Council

Research Topics

ANZSRC Field of Research (FoR)

Preventive Medicine

ANZSRC Socio-Economic Objective (SEO)

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Other Keywords

Cardiovascular - cerebrovascular | Clinical trial | Epidemiology | Folate | Multi-centre, placebo-controlled, double-blind trial | Prevention of stroke | Randomised controlled trial

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