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Nutrition Blood Outcomes Following Tocotrienol N2B (NIIB)

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ClinicalTrials.gov Identifier: NCT01858311
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Malaysia Palm Oil Board
Information provided by (Responsible Party):
Chandan K Sen, Ohio State University

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
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 Type : Observational
Estimated 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 : March 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E
U.S. FDA Resources

Group/Cohort 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)



Primary Outcome Measures :
  1. platelet aggregation activity [ Time Frame: up to 1 year ]
    Platelet aggregation activity will be measured using standard clinical laboratory procedures


Secondary Outcome Measures :
  1. Incidence of recurrent stroke [ Time Frame: up to 1 year ]
    Incidence of recurrent stroke after previous diagnosed stroke or TIA.


Biospecimen Retention:   Samples With DNA
Blood Draw


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke survivors within 6 months of clinical presentation for ischemic stroke or TIA event
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858311


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Mount Carmel Health System
Columbus, Ohio, United States, 43213
Sponsors and Collaborators
Ohio State University
Malaysia Palm Oil Board

Responsible Party: Chandan K Sen, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01858311     History of Changes
Other Study ID Numbers: 2012H0113
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by Chandan K Sen, Ohio State University:
Stroke survivors
TIA survivors
Vitamin E
Carotech
Tocotrienol

Additional relevant MeSH terms:
Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances