StrokePhase 3NCT00004734
Vitamin Therapy for Prevention of Stroke
A Phase 3 study testing pyridoxine, cyanocobalamin and folic acid multivitamin in people with Stroke and Cerebral Infarction, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Stroke, Cerebral Infarction, Myocardial Infarction
- What is being tested?
- pyridoxine, cyanocobalamin and folic acid multivitamin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1996to Feb 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1068
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Cerebral Infarction, Myocardial Infarction
- Being tested
- pyridoxine, cyanocobalamin, folic acid multivitamin
- Keywords
- stroke, cerebral infarction, homocysteine, vitamin, folic acid, pyridoxine, vitamin B6, cyanocobalamin, vitamin B12, multivitamin
- Medical subject headings
- Stroke, Cerebral Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyridoxineDrug
cyanocobalaminDrug
folic acid multivitaminDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2000 (estimated)
- Study startSep 1996
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- James F. Toole, M.D., Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004734
- Sponsor's protocol ID
- R01NS034447
- Status last verified
- Apr 2004
- First submitted
- 25 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin Intervention for Stroke Prevention
- ClinicalTrials.gov ID
- NCT00004734
- Acronym / sponsor ID
- R01NS034447
- Conditions
- Stroke, Cerebral Infarction, Myocardial Infarction
- Keywords
- stroke, cerebral infarction, homocysteine, vitamin, folic acid, pyridoxine, vitamin B6, cyanocobalamin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Sep 1996
- Study completion
- Feb 2004
- First posted
- 28 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pyridoxine | Drug | – |
| cyanocobalamin | Drug | – |
| folic acid multivitamin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James F. Toole, M.D. principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pyridoxine, cyanocobalamin and folic acid multivitamin in people with Stroke and Cerebral Infarction, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.