Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
---|---|
Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00004734 |
A stroke occurs when part of the brain is damaged from lack of normal blood supply. This may result in difficulty with feeling, speech, muscle strength or coordination, movement, thinking, or other brain functions. Having a stroke increases the risk of another stroke occurring in the future. Higher blood levels of a natural chemical known as homocysteine may contribute to hardening of the arteries in the brain or heart and increase the risk of stroke or heart attack. Folic acid, vitamin B6 (pyridoxine), and vitamin B12 (cyanocobalamin) may lower blood levels of homocysteine and reduce the risk of having another stroke or a heart attack.
Condition | Intervention | Phase |
---|---|---|
Stroke Cerebral Infarction Myocardial Infarction |
Drug: pyridoxine Drug: cyanocobalamin Drug: folic acid multivitamin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Vitamin Intervention for Stroke Prevention |
Study Start Date: | September 1996 |
Estimated Study Completion Date: | February 2004 |
The incidence of a second stroke in patients who have had a first stroke is between 7 and 10 percent per year. Myocardial infarction (heart attack) as a complication of stroke adds to stroke death and disability. Because homocysteine may be a major contributor to stroke, its reduction by appropriate intervention with vitamin supplements could reduce the impact of recurrent stroke, myocardial infarction, and vascular death. The purpose of this trial is to determine whether a multivitamin containing high-dose folic acid, pyridoxine, and cyanocobalamin, in addition to best medical/surgical management and risk factor modification, reduces the recurrence of stroke or occurrence of myocardial infarction in stroke patients with elevated homocysteine levels.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Wake Forest University School of Medicine | |
Winston Salem, North Carolina, United States, 27157-1068 |
Principal Investigator: | James F. Toole, M.D. | Wake Forest University |
Study ID Numbers: | R01NS34447 |
Study First Received: | February 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004734 |
Health Authority: | United States: Federal Government |
stroke cerebral infarction homocysteine vitamin folic acid |
pyridoxine vitamin B6 cyanocobalamin vitamin B12 multivitamin |
Heart Diseases Cerebral Infarction Myocardial Ischemia Hydroxocobalamin Stroke Vascular Diseases Vitamin B 12 Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Vitamin B 6 Folic Acid Necrosis Brain Ischemia Pyridoxine Brain Infarction Infarction Myocardial Infarction |
Vitamin B Complex Pathologic Processes Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Nervous System Diseases Cardiovascular Diseases Micronutrients Pharmacologic Actions |