Vitamin Therapy for Prevention of Stroke

NCT00004734 | Completed Phase 3

• 1 other identifier: R01NS034447
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Cerebral Infarction; Myocardial Infarction

Keywords

stroke; cerebral infarction; homocysteine; vitamin; folic acid; pyridoxine; vitamin B6; cyanocobalamin; vitamin B12; multivitamin

Interventions

pyridoxine DRUG

cyanocobalamin DRUG

folic acid multivitamin DRUG

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157-1068, United States

Location

MeSH Terms

Conditions

Stroke; Cerebral Infarction; Myocardial Infarction

Interventions

Pyridoxine; Vitamin B 12

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• James F. Toole, M.D.

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 25, 2000
• First Posted: February 28, 2000
• Study Start: September 1, 1996
• Study Completion: February 1, 2004
• Last Updated: June 24, 2005

Record last verified: 2004-04

Locations

US (1)