Vitamin Therapy for Prevention of Stroke

June 23, 2005 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

Vitamin Intervention for Stroke Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157-1068
        • Wake Forest University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: James F. Toole, M.D., Wake Forest University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1996

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

February 25, 2000

First Submitted That Met QC Criteria

February 25, 2000

First Posted (Estimate)

February 28, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NS034447 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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