NIIB: Nutrition Blood Outcomes Following Tocotrienol N2B

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT01858311

Collaborator

Malaysia Palm Oil Board (Other)

300

Enrollment

Locations

Duration (Months)

150

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Dietary Supplement: Tocotrienol Capsules Other: Placebo Vehicle

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

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Human Blood Outcomes Following Tocotrienol Supplementation - Nutrition Phase IIB NUTRITION PHASE IIB

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo vehicle (2) placebo capsules following AM meal and (2) placebo capsules following PM meal.	Other: Placebo Vehicle Placebo capsules per day (2 in the morning and 2 in the evening)
Tocotrienol capsules (400 mg) (2) 100mg TCT capsules following AM meal and (2) 100mg TCT capsules following PM meal.	Dietary Supplement: Tocotrienol Capsules Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)
Tocotrienol Capsules (800 mg) (2) 200mg TCT capsules following AM meal and (2) 200mg TCT capsules following PM meal.	Dietary Supplement: Tocotrienol Capsules Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)

Arm

Intervention/Treatment

Placebo vehicle

(2) placebo capsules following AM meal and (2) placebo capsules following PM meal.

Other: Placebo Vehicle

Placebo capsules per day (2 in the morning and 2 in the evening)

Tocotrienol capsules (400 mg)

(2) 100mg TCT capsules following AM meal and (2) 100mg TCT capsules following PM meal.

Dietary Supplement: Tocotrienol Capsules

Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)

Tocotrienol Capsules (800 mg)

(2) 200mg TCT capsules following AM meal and (2) 200mg TCT capsules following PM meal.

Dietary Supplement: Tocotrienol Capsules

Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)

Outcome Measures

Primary Outcome Measures

platelet aggregation activity [up to 1 year]
Platelet aggregation activity will be measured using standard clinical laboratory procedures

Secondary Outcome Measures

Incidence of recurrent stroke [up to 1 year]
Incidence of recurrent stroke after previous diagnosed stroke or TIA.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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