Nutrition Blood Outcomes Following Tocotrienol N2B

NCT01858311 | Completed DMC

• 1 other identifier: 2012H0113
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Stroke survivors; TIA survivors; Vitamin E; Carotech; Tocotrienol

Outcome Measures

Primary Outcomes (1)

• platelet aggregation activity

  Platelet aggregation activity will be measured using standard clinical laboratory procedures

  up to 1 year

Secondary Outcomes (1)

• Incidence of recurrent stroke

  up to 1 year

Study Arms (3)

Placebo vehicle

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

Other: Placebo Vehicle

Tocotrienol capsules (400 mg)

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

Dietary Supplement: Tocotrienol Capsules

Tocotrienol Capsules (800 mg)

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

Dietary Supplement: Tocotrienol Capsules

Interventions

Tocotrienol Capsules DIETARY_SUPPLEMENT

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

Tocotrienol Capsules (800 mg); Tocotrienol capsules (400 mg)

Placebo Vehicle OTHER

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

Placebo vehicle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke survivors within 6 months of clinical presentation for ischemic stroke or TIA event

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Malaysia Palm Oil Board: collaborator

Study Sites (2)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Mount Carmel Health System

Columbus, Ohio, 43213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Draw

MeSH Terms

Conditions

Stroke

Interventions

Tocotrienols

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor of Neurology

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 21, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

US (2)