StrokeNIIBNCT01858311
Nutrition Blood Outcomes Following Tocotrienol N2B
An observational study of Stroke, run by Ohio State University at 2 sites in United States.
Trial summary
A natural form of vitamin E called tocotrienol (TCT) has blood thinning and cholesterol lowering properties, both of which may benefit stroke survivors. This study is being conducted to determine the blood thinning and cholesterol lowering properties of TCT in stroke or TIA (transient ischemic attack, which is also… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Tocotrienol Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Dec 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stroke survivors within 6 months of clinical presentation for ischemic stroke or TIA event
Who may be able to join
- Patients with either atherothrombotic, cardioembolic, cryptogenic stroke or TIA (transient ischemic attack) for whom anticoagulation is not indicated
- Enrollment in trial must occur within 6 months of clinical presentation for first stroke or TIA event
- No history of long-term vitamin E supplement (defined as daily oral tocopherol or tocotrienol supplementation at least 6mos; within the past 5 years)
- No current vitamin E supplementation in multi-vitamin
Who cannot join
- Disabling stroke ( Modified Rankin Scale > 3)
- Prior intracranial hemorrhage (excluding traumatic)
- High risk of bleeding (recurrent gastrointestinal, genitourinary bleeding, active peptic ulcer disease)
- Anticipated requirement for long term use of anticoagulation
- Contraindications to antiplatelet agents (bleeding disorder, thrombocytopenia, prolonged INR)
- Irreversible medical condition likely to affect short-term survival or ability to participate in study such as cancer or other chronic disease with predicted survival of less than a year or severe psychiatric or neurologic disease that might complicate evaluation of study outcomes like dementia or schizophrenia
Show all 12Show fewer
- Pregnancy or women of child bearing age who are not following an effective method of contraception
- Breast feeding
- Unable or unwilling to provide informed
- Unlikely to be compliant with therapy or unwilling to return for follow up frequent clinic visits
- Concurrent participation in another study with an investigational drug or devise
- Other likely specific cause of stroke such as dissection, infectious or noninfectious vasculitis, prothrombotic state
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University
Columbus, Ohio, 43210
Mount Carmel Health System
Columbus, Ohio, 43213
About this study
Official title: Human Blood Outcomes Following Tocotrienol Supplementation - Nutrition Phase IIB NUTRITION PHASE IIB
A natural form of vitamin E called tocotrienol (TCT) has blood thinning and cholesterol lowering properties, both of which may benefit stroke survivors. This study is being conducted to determine the blood thinning and cholesterol lowering properties of TCT in stroke or TIA (transient ischemic attack, which is also referred to as a "mini-stroke") survivors that are receiving the standard treatment for prevention of recurrent stroke.
Study Hypothesis: Oral TCT decreases the incidence of aspirin and clopidogrel nonresponders, increases the extent of inhibition of platelet aggregation, and decreases LDL without significant side effects in stroke patients.
Read the detailed description
In this Phase IIB trial the goal is to determine the effects of orally supplemented TCT on platelet function and cholesterol as well as the safety in patients with TIA (transient ischemic attack) or stroke in addition to the standard treatment for stroke prevention. Recurrent cardiovascular events including stroke, TIA, heart attack, venous thrombosis, pulmonary embolism, systemic embolism will also be recorded. In patients with recurrent stroke, severity of the stroke and stroke size measured from MR (magnetic resonance) or CT (computed tomography) imaging will also be collected. We expect that TCT will inhibit blood clotting and lower cholesterol more than current standard treatment without significantly increasing bleeding risks or other side effects. Future work is planned in a larger TIA/stroke population to examine whether TCT adds to standard medical care in terms of decreasing incidence of stroke and improving outcomes following stroke.
- Conditions
- Stroke
- Being tested
- Tocotrienol Capsules, Placebo Vehicle
- Keywords
- Stroke survivors, TIA survivors, Vitamin E, Carotech, Tocotrienol
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocotrienol CapsulesDietary supplement
Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)
Placebo VehicleOther
Placebo capsules per day (2 in the morning and 2 in the evening)
| Study group | Role | What they receive |
|---|---|---|
| Placebo vehicle | (2) placebo capsules following AM meal and (2) placebo capsules following PM meal. Receives: Other: Placebo Vehicle | |
| Tocotrienol capsules (400 mg) | (2) 100mg TCT capsules following AM meal and (2) 100mg TCT capsules following PM meal. Receives: Dietary Supplement: Tocotrienol Capsules | |
| Tocotrienol Capsules (800 mg) | (2) 200mg TCT capsules following AM meal and (2) 200mg TCT capsules following PM meal. Receives: Dietary Supplement: Tocotrienol Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet aggregation activity
Platelet aggregation activity will be measured using standard clinical laboratory procedures
Measured: up to 1 year
Secondary outcomes (1)
Incidence of recurrent stroke
Incidence of recurrent stroke after previous diagnosed stroke or TIA.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2018
- Study completionDec 2018
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 Ohio State UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Responsible party
- Principal investigator, Andrew Slivka, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858311
- Sponsor's protocol ID
- 2012H0113
- Acronym
- NIIB
- Status last verified
- Sep 2021
- First submitted
- 9 May 2013
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Blood Outcomes Following Tocotrienol Supplementation - Nutrition Phase IIB NUTRITION PHASE IIB
- ClinicalTrials.gov ID
- NCT01858311
- Acronym / sponsor ID
- NIIB / 2012H0113
- Conditions
- Stroke
- Keywords
- Stroke survivors, TIA survivors, Vitamin E, Carotech, Tocotrienol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Study start
- Mar 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 May 2013 (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 natural form of vitamin E called tocotrienol (TCT) has blood thinning and cholesterol lowering properties, both of which may benefit stroke survivors. This study is being conducted to determine the blood thinning and cholesterol lowering properties of TCT in stroke or TIA (transient ischemic attack, which is also referred to as a "mini-stroke") survivors that are receiving the standard treatment for prevention of recurrent stroke.
Study Hypothesis: Oral TCT decreases the incidence of aspirin and clopidogrel nonresponders, increases the extent of inhibition of platelet aggregation, and decreases LDL without significant side effects in stroke patients.
Detailed description
In this Phase IIB trial the goal is to determine the effects of orally supplemented TCT on platelet function and cholesterol as well as the safety in patients with TIA (transient ischemic attack) or stroke in addition to the standard treatment for stroke prevention. Recurrent cardiovascular events including stroke, TIA, heart attack, venous thrombosis, pulmonary embolism, systemic embolism will also be recorded. In patients with recurrent stroke, severity of the stroke and stroke size measured from MR (magnetic resonance) or CT (computed tomography) imaging will also be collected. We expect that TCT will inhibit blood clotting and lower cholesterol more than current standard treatment without significantly increasing bleeding risks or other side effects. Future work is planned in a larger TIA/stroke population to examine whether TCT adds to standard medical care in terms of decreasing incidence of stroke and improving outcomes following stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo vehicle | – | Other: Placebo Vehicle(2) placebo capsules following AM meal and (2) placebo capsules following PM meal. |
| Tocotrienol capsules (400 mg) | – | Dietary Supplement: Tocotrienol Capsules(2) 100mg TCT capsules following AM meal and (2) 100mg TCT capsules following PM meal. |
| Tocotrienol Capsules (800 mg) | – | Dietary Supplement: Tocotrienol Capsules(2) 200mg TCT capsules following AM meal and (2) 200mg TCT capsules following PM meal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stroke survivors within 6 months of clinical presentation for ischemic stroke or TIA event
Key inclusion criteria (4 listed)
- Patients with either atherothrombotic, cardioembolic, cryptogenic stroke or TIA (transient ischemic attack) for whom anticoagulation is not indicated
- Enrollment in trial must occur within 6 months of clinical presentation for first stroke or TIA event
- No history of long-term vitamin E supplement (defined as daily oral tocopherol or tocotrienol supplementation at least 6mos; within the past 5 years)
- No current vitamin E supplementation in multi-vitamin
Key exclusion criteria (12 listed)
- Disabling stroke ( Modified Rankin Scale > 3)
- Prior intracranial hemorrhage (excluding traumatic)
- High risk of bleeding (recurrent gastrointestinal, genitourinary bleeding, active peptic ulcer disease)
- Anticipated requirement for long term use of anticoagulation
- Contraindications to antiplatelet agents (bleeding disorder, thrombocytopenia, prolonged INR)
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 |
|---|---|---|
| Tocotrienol CapsulesVitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening) | Dietary supplement | Tocotrienol Capsules (800 mg), Tocotrienol capsules (400 mg) |
| Placebo VehiclePlacebo capsules per day (2 in the morning and 2 in the evening) | Other | Placebo vehicle |
Primary outcome
platelet aggregation activity
Time frame: up to 1 year
Platelet aggregation activity will be measured using standard clinical laboratory procedures
1 secondary outcome
Incidence of recurrent stroke
Time frame: up to 1 year
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 20 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Ohio State University at 2 sites 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 4 inclusion and 12 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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.
What does the primary outcome measure?
platelet aggregation activity (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
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 20 Sep 2021.