Status:
COMPLETED
Nutrition Blood Outcomes Following Tocotrienol N2B
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Malaysia Palm Oil Board
Conditions:
Stroke
Eligibility:
All Genders
Brief 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 ...
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01858311
Start Date
March 1 2013
End Date
December 1 2018
Last Update
September 20 2021
Active Locations (2)
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1
The Ohio State University
Columbus, Ohio, United States, 43210
2
Mount Carmel Health System
Columbus, Ohio, United States, 43213