NCT01858311

Nutrition Blood Outcomes Following Tocotrienol N2B

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tocotrienol Capsules	Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)
OTHER	Placebo Vehicle	Placebo capsules per day (2 in the morning and 2 in the evening)

Timeline

• Start date: 2013-03-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2013-05-21
• Last updated: 2021-09-20

Locations

2 sites across 1 country: United States