VITATOPS

To determine whether vitamin supplements (folic acid 2 mg, B6 25 mg, B12 500 ug) reduce the risk of stroke, other serious vascular events, dementia and depression in patients with recent stroke or transient ischemic attacks of the brain or eye (TIA).

Official Title

VITATOPS: A Study of VITAmins TO Prevent Stroke

Conditions

– Stroke- Transient Ischemic Attack

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B12 and vitamin B6, it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events, dementia and depression.

• Primary outcome measure: Non-fatal stroke; non-fatal myocardial infarction; death due to vascular causes.
• Secondary outcome measures: TIA; Revascularisation procedures; Dementia; Depression.

Conclusion: VITATOPS aims to recruit and follow up 8,000 patients between 2000 and 2006, and provide a reliable estimate of the safety and effectiveness of dietary supplementation with folic acid, vitamin B12, and vitamin B6 in reducing recurrent serious vascular events, dementia and depression among a wide range of patients with stroke and TIA.

Study Start

November 1998, Expected completion: June 2008

Eligibility & Criteria

Inclusion Criteria:

• Patients presenting within seven months of stroke (ischemic or hemorrhagic) or TIA
• Agree to take study medication
• Be geographically accessible for follow-up
• Provide written informed consent

Exclusion Criteria:

• Taking folic acid or B6 on medical advice
• Use of vitamin supplements containing folate, B6 or B12 (unless patient agrees to take study medication instead of the vitamin supplements which they usually take)
• Taking Methotrexate for any reason
• Pregnancy or women of child-bearing potential who are at risk of pregnancy
• Limited life expectancy

Total Enrolment

8000

Contact Details

Royal Perth Hospital, Perth, Western Australia, 6000, Australia; Recruiting

• Katherine Loh +61892242443 gjhankey@cyllene.uwa.edu.au
• Julia Pizzi +61 8 9224 7004 VITATOPS@health.wa.gov.au
• Michelle Tang +61 8 9224 3336 VITATOPS@health.wa.gov.au