Vitamin Therapy for Prevention of Stroke

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00004734
First received: February 25, 2000
Last updated: June 23, 2005
Last verified: April 2004
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Vitamin Intervention for Stroke Prevention

Resource links provided by NLM:


Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Study Start Date: September 1996
Estimated Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004734

Locations
United States, North Carolina
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157-1068
Sponsors and Collaborators
Investigators
Principal Investigator: James F. Toole, M.D. Wake Forest School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004734     History of Changes
Other Study ID Numbers: R01NS34447
Study First Received: February 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke
cerebral infarction
homocysteine
vitamin
folic acid
pyridoxine
vitamin B6
cyanocobalamin
vitamin B12
multivitamin

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Myocardial Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Folic Acid
Hydroxocobalamin
Vitamin B Complex
Vitamin B 12
Pyridoxine
Vitamin B 6
Pyridoxal
Vitamins
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients

ClinicalTrials.gov processed this record on August 26, 2014