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Vitamin Intervention for Stroke Prevention (VISP) trial: rationale and design
J D Spence1, V J Howard, L E Chambless
1Robarts Research Institute, London, Ont., Canada.
Neuroepidemiology
|February 15, 2001
Summary
High doses of folic acid, vitamin B6, and vitamin B12 may help prevent recurrent stroke in patients with elevated homocyst(e)ine levels. The VISP study investigates if these vitamin supplements reduce stroke risk compared to lower doses.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Nutritional Science
Background:
- Elevated plasma homocyst(e)ine [H(e)] is linked to endothelial dysfunction and increased vascular risk.
- While B vitamins (folic acid, B6, B12) lower H(e) and improve endothelial function, their effect on clinical events is unproven.
- Carotid plaque regression has been observed with B vitamin therapy, but clinical event reduction remains uncertain.
Purpose of the Study:
- To determine if high-dose folic acid, vitamin B6, and vitamin B12 supplements reduce recurrent stroke risk in patients with elevated H(e).
- To compare the efficacy of high-dose versus lower-dose B vitamin supplementation in preventing secondary stroke events.
- To evaluate the impact of B vitamin intervention on secondary cardiovascular outcomes like myocardial infarction and fatal coronary heart disease.
Main Methods:
- The Vitamin Intervention for Stroke Prevention (VISP) is a double-masked, randomized, multicenter clinical trial.
- Participants are adults (≥35 years) with recent nondisabling ischemic stroke and elevated screening plasma H(e) (>25th percentile).
- Intervention involves high-dose versus lower-dose B vitamin supplements (folic acid, B6, B12) alongside standard medical/surgical care.
Main Results:
- This paper focuses on the study's design and rationale, not preliminary or final results.
- The trial is designed to provide evidence on the effectiveness of B vitamin supplementation in stroke prevention.
- Data collection and analysis will determine if high-dose vitamins significantly reduce recurrent stroke or other vascular events.
Conclusions:
- The VISP study aims to clarify the role of B vitamin supplementation in reducing vascular risk and recurrent stroke in specific patient populations.
- Understanding the clinical impact of lowering homocyst(e)ine levels through B vitamin therapy is crucial for cardiovascular and neurological patient management.
- The findings are expected to inform clinical guidelines regarding the use of B vitamins for secondary stroke prevention.