MedDataX Logo

Vitamin Therapy for Prevention of Stroke

NCT ID: NCT00004734

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1996-09-30

Study Completion Date

2004-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Cerebral Infarction Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pyridoxine

Intervention Type DRUG

cyanocobalamin

Intervention Type DRUG

folic acid multivitamin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James F. Toole, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01NS034447

Identifier Type: NIH

Identifier Source: org_study_id

View Link