Ischemic StrokePhase 1/2NUTRITIONNCT01578629
NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event
A Phase 1/2 study testing Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by Andrew Slivka at 1 site in United States.
Trial summary
A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and lowers cholesterol, which make it a potential therapy for stroke prevention, though these effects are less well characterized for TCT. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack (TIA)
- What is being tested?
- Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2018
- Phase
- Phase 1/2
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects between 40 and 70 years of age
- No history of long-term vitamin E supplement (defined as daily oral tocopherol or tocotrienol supplementation greater than or equal to 6mos; within the past 5 years)
- No current vitamin E supplementation in multivitamin
- Exclusion Criteria - (as self reported by potential participants during review of eligibility criteria with Research Nurse,)
- Evidence of heart disease as diagnosed by a physician by one or more of the following tests; EKG, chest x-ray, stress test, tilt table test, echocardiogram, coronary angiogram, electrophysiology test, CT heart scan, coronary MRI, pericardiocentesis
- High cholesterol (total cholesterol >240mg/dL, LDL>160mg/dL)
Show all 19Show fewer
- Prior cancer diagnosis
- Pregnancy - To exclude the possibility of pregnant women entering the study or becoming pregnant during the study only post-menopausal women or women who have had hysterectomies or bilateral oophorectomies will be included.
- Breast feeding
- Smoker (Must have quit 5 or more years ago)
- Alcohol dependence (>4 drinks per day for more than 1yr anytime in the last 3 years)
- Medication exclusion criteria - current use or recent discontinuation (within last 28 days) of any medication including the following: anti-coagulants and blood-thinners (e.g., Warfarin), psychotropic medications including antipsychotics, mood-stabilizers (e.g., lithium, valproic acid, carbamazepine/tegretol); anti-depressants (tricyclics, SSRI's, MAOI's, nonselective MAOIs, Wellbutrin, St. John's Wort); anti-anxiety/anti-panic agents; anti-obsessive agents; prescription stimulants (e.g., Provigil, Ritalin); diet pills/anorectics; daily medication for chronic pain (e.g., opiates) or muscle spasms; daily use of over the counter stimulants in pill form (e.g., ephedrine); daily medication for asthma, Parkinson's disease medications (e.g., levodopa, methyldopa, apomorphine), smoking cessation medications (Wellbutrin/Zyban, Chantix/varenicline); statin use is not grounds for exclusion.
- Phase IIA
- Hyperlipidemic patients between 40 and 70 years of age currently taking statins
- LDL>130mg/dL
- TG>150mg/dL
- HDL<40mg/dL
- No history of long-term vitamin E supplement (defined as daily oral tocopherol or tocotrienol supplementation greater than or equal to 6mos; within the past 5 years)
- No current vitamin E supplementation in multivitamin
Who cannot join
- Evidence of heart disease as diagnosed by a physician by one or more of the following tests; EKG, chest x-ray, stress test, tilt table test, echocardiogram, coronary angiogram, electrophysiology test, CT heart scan, coronary MRI, pericardiocentesis
- Prior cancer diagnosis
- Currently taking blood thinners
- Pregnancy - To exclude the possibility of pregnant women entering the study or becoming pregnant during the study only post-menopausal women or women who have had hysterectomies or bilateral oophorectomy will be included.
- Breast feeding
- Smoking (Must have quit within the past 6 months)
- Alcohol dependence - (>4 drinks per day for more than 1yr anytime in the last 3 years)
- Medication exclusion criteria - current use or recent discontinuation (within last 28 days) of any medication including the following: anti-coagulants and blood-thinners (e.g., Warfarin), psychotropic medications including antipsychotics, mood-stabilizers (e.g., lithium, valproic acid, carbamazepine/tegretol); anti-depressants (tricyclics, SSRI's, MAOI's, nonselective MAOIs, Wellbutrin, St. John's Wort); anti-anxiety/anti-panic agents; anti-obsessive agents; prescription stimulants (e.g., Provigil, Ritalin); diet pills/anorectics; daily medication for chronic pain (e.g., opiates) or muscle spasms; daily use of over the counter stimulants in pill form (e.g., ephedrine); daily medication for asthma, Parkinson's disease medications (e.g., levodopa, methyldopa, apomorphine), smoking cessation medications (Wellbutrin/Zyban, Chantix/varenicline)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio state University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA
A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and lowers cholesterol, which make it a potential therapy for stroke prevention, though these effects are less well characterized for TCT. We plan to conduct two trials (I \& IIA) to determine the effects of orally supplemented TCT on platelet function and cholesterol.
Read the detailed description
A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and lowers cholesterol, which make it a potential therapy for stroke prevention, though these effects are less well characterized for TCT. We plan to conduct two trials (I \& IIA) to determine the effects of orally supplemented TCT on platelet function and cholesterol. Phase I subjects will be healthy volunteers, recruited by an advertisement. Phase IIA subjects will be hyperlipidemic (having high cholesterol), and will be referred to us by their Wound Care Center Physicians. Patients will be randomized to receive placebo pills, (400 or 800 mg) TCT pills, low-dose 81 mg aspirin (commonly used for secondary prevention of stroke), or TCT and aspirin together. Potential subjects for Phase-I who meet study criteria and agree to participate will be in the study for 6 months and have the following study related procedures, blood draw total 4 times, tape stripping (non-invasive procedure), BMI, and blood pressure measurement at each visit (every month). Participants in Phase-IIA will have blood drawn a total of 6 times, tape stripping, BMI and blood pressure measurement and participants will be in the study for 13 months.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack (TIA)
- Being tested
- Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin, Placebo vehicle control
- Keywords
- stroke, ischemia, TIA
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E tocotrienol (TCT) capsules ; Low dose AspirinOther
Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg
Placebo vehicle controlOther
Also called placebo capsule
vehicle control compared to Vitamin E TCT pills
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Active comparator | Healthy participants randomized into one of 6 groups that will take 4 capsules, twice a day of vitamin E tocotrienol (TCT) capsules ; Low Dose Aspirin or placebo capsule for 7 months. Receives: Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin; Other: Placebo vehicle control |
| Hyperlipidemic | Active comparator | hyperlipidemic patients randomized into one of 6 groups that will take 4 capsules, twice a day of Vitamin E Tocotrienol (TCT) capsules; Low Dose Aspirin or placebo vehicle control capsule for 7 months. Receives: Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin; Other: Placebo vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function panel
Blood draw followed by platelet aggregometry
Measured: up to one year
Lipid profile
blood lipid panel including HDL, LDL, total cholesterol
Measured: up to one year
Secondary outcomes (1)
Tape Stripping Test
HPLC vitamin E analysis of tape strips for compliance
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionNov 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 Ischemic StrokeStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Slivka
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Malaysia
- Responsible party
- Sponsor-investigator, Andrew Slivka, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578629
- Sponsor's protocol ID
- 2011H0242
- Acronym
- NUTRITION
- Status last verified
- Sep 2021
- First submitted
- 5 Apr 2012
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
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 I and Phase IIA
- ClinicalTrials.gov ID
- NCT01578629
- Acronym / sponsor ID
- NUTRITION / 2011H0242
- Conditions
- Ischemic Stroke, Transient Ischemic Attack (TIA)
- Keywords
- stroke, ischemia, TIA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Andrew SlivkaUniversity, hospital or other
- Collaborators
- Government of Malaysia
- Study start
- Mar 2012
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 17 Apr 2012 (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), found in many common foods such as barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and lowers cholesterol, which make it a potential therapy for stroke prevention, though these effects are less well characterized for TCT. We plan to conduct two trials (I \& IIA) to determine the effects of orally supplemented TCT on platelet function and cholesterol.
Detailed description
A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and lowers cholesterol, which make it a potential therapy for stroke prevention, though these effects are less well characterized for TCT. We plan to conduct two trials (I \& IIA) to determine the effects of orally supplemented TCT on platelet function and cholesterol. Phase I subjects will be healthy volunteers, recruited by an advertisement. Phase IIA subjects will be hyperlipidemic (having high cholesterol), and will be referred to us by their Wound Care Center Physicians. Patients will be randomized to receive placebo pills, (400 or 800 mg) TCT pills, low-dose 81 mg aspirin (commonly used for secondary prevention of stroke), or TCT and aspirin together. Potential subjects for Phase-I who meet study criteria and agree to participate will be in the study for 6 months and have the following study related procedures, blood draw total 4 times, tape stripping (non-invasive procedure), BMI, and blood pressure measurement at each visit (every month). Participants in Phase-IIA will have blood drawn a total of 6 times, tape stripping, BMI and blood pressure measurement and participants will be in the study for 13 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Active comparator | Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin, Other: Placebo vehicle controlHealthy participants randomized into one of 6 groups that will take 4 capsules, twice a day of vitamin E tocotrienol (TCT) capsules ; Low Dose Aspirin or placebo capsule for 7 months. |
| Hyperlipidemic | Active comparator | Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin, Other: Placebo vehicle controlhyperlipidemic patients randomized into one of 6 groups that will take 4 capsules, twice a day of Vitamin E Tocotrienol (TCT) capsules; Low Dose Aspirin or placebo vehicle control capsule for 7 months. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Healthy subjects between 40 and 70 years of age
- No history of long-term vitamin E supplement (defined as daily oral tocopherol or tocotrienol supplementation greater than or equal to 6mos; within the past 5 years)
- No current vitamin E supplementation in multivitamin
- Exclusion Criteria - (as self reported by potential participants during review of eligibility criteria with Research Nurse,)
- Evidence of heart disease as diagnosed by a physician by one or more of the following tests; EKG, chest x-ray, stress test, tilt table test, echocardiogram, coronary angiogram, electrophysiology test, CT heart scan, coronary MRI, pericardiocentesis
Key exclusion criteria (8 listed)
- Evidence of heart disease as diagnosed by a physician by one or more of the following tests; EKG, chest x-ray, stress test, tilt table test, echocardiogram, coronary angiogram, electrophysiology test, CT heart scan, coronary MRI, pericardiocentesis
- Prior cancer diagnosis
- Currently taking blood thinners
- Pregnancy - To exclude the possibility of pregnant women entering the study or becoming pregnant during the study only post-menopausal women or women who have had hysterectomies or bilateral oophorectomy will be included.
- Breast feeding
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 |
|---|---|---|
| Vitamin E tocotrienol (TCT) capsules ; Low dose AspirinVitamin E TCT capsules- 400-800 mg Aspirin- 81 mg | Other | Healthy Volunteers, Hyperlipidemic |
| Placebo vehicle controlAlso: placebo capsulevehicle control compared to Vitamin E TCT pills | Other | Healthy Volunteers, Hyperlipidemic |
Primary outcome
Platelet function panel
Time frame: up to one year
Blood draw followed by platelet aggregometry
Lipid profile
Time frame: up to one year
blood lipid panel including HDL, LDL, total cholesterol
1 secondary outcome
Tape Stripping Test
Time frame: up to one 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by Andrew Slivka 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 19 inclusion and 8 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Platelet function panel (time frame: up to one year). The study lists 2 primary outcomes in all. 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.