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Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00678834
Recruitment Status : Completed
First Posted : May 16, 2008
Results First Posted : September 16, 2014
Last Update Posted : September 16, 2014
Sponsor:
Collaborator:
Carotech Inc.
Information provided by (Responsible Party):
Chandan K Sen, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Conditions End Stage Cardiac Failure
Pulmonary Failure
End Stage Liver Disease
Morbid Obesity
Recalcitrant Epilepsy Requiring Surgery
Healthy Subjects
Interventions Dietary Supplement: To surgery patients, Tocopherol capsules.
Dietary Supplement: Tocotrienol to healthy subjects.
Dietary Supplement: To surgery patients, Tocotrienol capsules.
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1- Surgery + Tocotrienol 200 mg Arm 2- Surgery + Tocopherol 200 mg Arm 3- Healthy +Tocotrienol 400 mg
Hide Arm/Group Description Surgery Patients to take Tocotrienol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily Surgery Patients to take Tocopherol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily Healthy patients to take Tocotrienol: 400 mg to take orally (two 200 mg capsules) two times a day.
Period Title: Overall Study
Started 40 15 25
Completed 24 15 16
Not Completed 16 0 9
Arm/Group Title Arm 1- Surgical + Tocotrienol 200 mg Arm 2 - Surgical + Tocopherol 200 mg Arm 3- Healthy + Tocotrienol 200 mg Total
Hide Arm/Group Description Surgical Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day Surgical Subjects will recieve Tocopherol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day Healthy Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day Total of all reporting groups
Overall Number of Baseline Participants 40 15 25 80
Hide Baseline Analysis Population Description
The healthy participants included: age 21–40 y, good health, nonsmoker, nonpregnant or nonbreastfeeding, and no recent (past 6 mo) or current use of supplements containing vitamin E. The surgical participants group included adipose, brain, cardiac muscle, and liver tissue of the surgical participants age 21 and older.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 15 participants 25 participants 80 participants
49.37  (12.81) 54  (11.56) 30.24  (8.59) 40.37  (4.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 15 participants 25 participants 80 participants
Female
20
  50.0%
10
  66.7%
13
  52.0%
43
  53.8%
Male
20
  50.0%
5
  33.3%
12
  48.0%
37
  46.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 15 participants 25 participants 80 participants
40 15 25 80
1.Primary Outcome
Title The Levels of TCT in the Tissues of "Non-healthy" Subjects and in the Tissue of "Healthy" Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)
Hide Description [Not Specified]
Time Frame After at least 1 month of supplementation
Hide Outcome Measure Data
Hide Analysis Population Description
Box plots were used to determine outliers defined as values . the 75th percentile plus 1.5 times the IQR or values , the 25th percentile minus 1.5 times the IQR (20). Outliers were identified and it was determined that laboratory procedural errors were the cause and thus removed from the analysis.
Arm/Group Title Arm 1: Surgical, Adipose Arm 1: Surgical, Brain Arm 1: Surgical, Heart Arm 1: Surgical, Liver Arm 2: Surgical, Adipose Arm 2: Surgical, Brain Arm 2: Surgical, Heart Arm 2: Surgical, Liver Arm 3: Healthy, Blood, Week 0 Arm 3: Healthy, Blood, Week 6 Arm 3: Healthy, Skin, Week 12 Arm 3: Healthy, Skin, Week 0 Arm 3: Healthy, Blood, Week 12
Hide Arm/Group Description:
adipose aTE levels after supplementation (400mg/d)
brain aTE levels after supplementation (400mg/d)
heart aTE levels after supplementation (400mg/d)
liver aTE levels after supplementation (400mg/d)
adipose aTCP levels after supplementation (400mg/d)
brain aTCP levels after supplementation (400mg/d)
heart aTCP levels after supplementation (400mg/d)
liver aTCP levels after supplementation (400mg/d)
Baseline blood levels of aTE prior to supplementation
Blood levels of aTE after 6 weeks of supplementation (400mg/d)
skin levels of aTE after 12 weeks of supplementation (400mg/d)
baseline skin levels of aTE prior to supplementation
Blood levels of aTE after 12 weeks of supplementation (400mg/d)
Overall Number of Participants Analyzed 5 4 5 4 4 4 3 3 16 16 16 16 16
Mean (Standard Deviation)
Unit of Measure: nmol/g
9.94  (6.9) 1.29  (1.06) 5.37  (4.28) 0.42  (0.43) 28.6  (20.7) 50.5  (17.2) 31.9  (20.0) 64.3  (14.9) 0.01  (0.02) 1.9  (0.7) 1.5  (1.8) 2.5  (3.0) 0.03  (0.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description Surgery patients to take Tocotrienol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily Surgery patients to take Tocopherol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily Healthy patients to take either Tocotrienol or Tocopherol: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
All-Cause Mortality
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/15 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/15 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Chandan K. Sen, PhD. Professor and Associate Dean
Organization: The Ohio State University Wexner Medical Center
Phone: 614-247-7658
EMail: chandan.sen@osumc.edu
Layout table for additonal information
Responsible Party: Chandan K Sen, Ohio State University
ClinicalTrials.gov Identifier: NCT00678834    
Other Study ID Numbers: 2005C0034
First Submitted: May 14, 2008
First Posted: May 16, 2008
Results First Submitted: July 2, 2014
Results First Posted: September 16, 2014
Last Update Posted: September 16, 2014