Vitamin Therapy for Prevention of Stroke
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00004734 |
Recruitment Status :
Completed
First Posted : February 28, 2000
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Cerebral Infarction Myocardial Infarction | Drug: pyridoxine Drug: cyanocobalamin Drug: folic acid multivitamin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Vitamin Intervention for Stroke Prevention |
Study Start Date : | September 1996 |
Study Completion Date : | February 2004 |

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Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Any stroke (non-disabling cerebral infarction, NDCI) < 120 days prior to randomization
- Symptoms lasting > 24 hrs, or if < 24 hrs, CT or MRI shows new infarction at expected site
- Modified Rankin score < 3
- Homocysteine level > the 25th percentile, ie, 9.5 mol/L for men, and 8.5 mol/L for women
- Patient compliance with multivitamin during run-in phase > 75%
Exclusion Criteria:
- Stroke due to: intracranial hemorrhage, dissection of a cervico-cephalic artery, veno-occlusive disease, drug abuse, vasculitis
- CT or MRI shows lesion other than infarction as cause of syndrome
- Modified Rankin score of 4 or 5 at eligibility
- Presence of potential sources of cardiogenic emboli: atrial fibrillation, prosthetic cardiac valve, intracardiac thrombus or neoplasm, valvular vegetation
- Neurologic illness other than stroke that would prevent proper evaluation of recurrent stroke
- Illness that limits life expectancy to < 2 years
- Severe congestive heart failure
- Renal insufficiency requiring dialysis
- Untreated B12 deficiency or untreated pernicious anemia
- Uncontrolled hypertension (systolic >185 mm/Hg or diastolic >105 mm/Hg on two readings separated by 5 min.) at eligibility
- Conditions preventing reliable participation in study: refractory depression, severe cognitive impairment, alcoholism, other substance abuse
- Medications given within last 30 days that affect homocysteine: methotrexate, tamoxifen, L-dopa, phenytoin, or bile acid sequestrants that can decrease folate levels
- Women of childbearing potential
- Patients receiving active intervention in another trial
- Patients on multi-vitamins, single B6, or folic acid, unless willing to discontinue and take study supplement
- Any surgical procedure, invasive cardiac instrumentation, endarterectomy, stent placement, thrombectomy or other endovascular treatment of abnormal carotid artery performed within 30 days prior to randomization or scheduled within 30 days after randomization

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004734
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 |
ClinicalTrials.gov Identifier: | NCT00004734 |
Other Study ID Numbers: |
R01NS034447 ( U.S. NIH Grant/Contract ) |
First Posted: | February 28, 2000 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | April 2004 |
stroke cerebral infarction homocysteine vitamin folic acid |
pyridoxine vitamin B6 cyanocobalamin vitamin B12 multivitamin |
Stroke Cerebral Infarction Myocardial Infarction Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Brain Infarction Brain Ischemia Folic Acid Pyridoxine Vitamin B 12 Hydroxocobalamin Hematinics Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs |