Ischemic Stroke, Transient Ischemic Attack (TIA)
Conditions
Keywords
stroke, ischemia, TIA
Brief 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. 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.
Interventions
OTHERVitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg
OTHERPlacebo vehicle control
vehicle control compared to Vitamin E TCT pills
Sponsors
Government of Malaysia
Andrew Slivka
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Phase IA Inclusion Criteria: * 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet function panel | up to one year | Blood draw followed by platelet aggregometry |
| Lipid profile | up to one year | blood lipid panel including HDL, LDL, total cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tape Stripping Test | up to one year | HPLC vitamin E analysis of tape strips for compliance |
Countries
United States
Outcome results
None listed