Trial Outcomes & Findings for Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol (NCT NCT00678834)

Results Overview

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

80 participants

Primary outcome timeframe

After at least 1 month of supplementation

Results posted on

2014-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1- Surgery + Tocotrienol 200 mg Surgery Patients to take Tocotrienol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily	Arm 2- Surgery + Tocopherol 200 mg Surgery Patients to take Tocopherol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily	Arm 3- Healthy +Tocotrienol 400 mg Healthy patients to take Tocotrienol: 400 mg to take orally (two 200 mg capsules) two times a day.
Overall Study STARTED	40	15	25
Overall Study COMPLETED	24	15	16
Overall Study NOT COMPLETED	16	0	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1- Surgical + Tocotrienol 200 mg n=40 Participants Surgical Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day	Arm 2 - Surgical + Tocopherol 200 mg n=15 Participants Surgical Subjects will recieve Tocopherol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day	Arm 3- Healthy + Tocotrienol 200 mg n=25 Participants 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 n=80 Participants Total of all reporting groups
Age, Continuous	49.37 years STANDARD_DEVIATION 12.81 • n=5 Participants	54 years STANDARD_DEVIATION 11.56 • n=7 Participants	30.24 years STANDARD_DEVIATION 8.59 • n=5 Participants	40.37 years STANDARD_DEVIATION 4.61 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants	37 Participants n=4 Participants
Region of Enrollment United States	40 participants n=5 Participants	15 participants n=7 Participants	25 participants n=5 Participants	80 participants n=4 Participants

PRIMARY outcome

Timeframe: After at least 1 month of supplementation

Population: 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.

Outcome measures

Outcome measures
Measure	Arm 1: Surgical, Adipose n=5 Participants adipose aTE levels after supplementation (400mg/d)	Arm 1: Surgical, Brain n=4 Participants brain aTE levels after supplementation (400mg/d)	Arm 1: Surgical, Heart n=5 Participants heart aTE levels after supplementation (400mg/d)	Arm 1: Surgical, Liver n=4 Participants liver aTE levels after supplementation (400mg/d)	Arm 2: Surgical, Adipose n=4 Participants adipose aTCP levels after supplementation (400mg/d)	Arm 2: Surgical, Brain n=4 Participants brain aTCP levels after supplementation (400mg/d)	Arm 2: Surgical, Heart n=3 Participants heart aTCP levels after supplementation (400mg/d)	Arm 2: Surgical, Liver n=3 Participants liver aTCP levels after supplementation (400mg/d)	Arm 3: Healthy, Blood, Week 0 n=16 Participants Baseline blood levels of aTE prior to supplementation	Arm 3: Healthy, Blood, Week 6 n=16 Participants Blood levels of aTE after 6 weeks of supplementation (400mg/d)	Arm 3: Healthy, Skin, Week 12 n=16 Participants skin levels of aTE after 12 weeks of supplementation (400mg/d)	Arm 3: Healthy, Skin, Week 0 n=16 Participants baseline skin levels of aTE prior to supplementation	Arm 3: Healthy, Blood, Week 12 n=16 Participants Blood levels of aTE after 12 weeks of supplementation (400mg/d)
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)	9.94 nmol/g Standard Deviation 6.9	1.29 nmol/g Standard Deviation 1.06	5.37 nmol/g Standard Deviation 4.28	0.42 nmol/g Standard Deviation 0.43	28.6 nmol/g Standard Deviation 20.7	50.5 nmol/g Standard Deviation 17.2	31.9 nmol/g Standard Deviation 20.0	64.3 nmol/g Standard Deviation 14.9	0.01 nmol/g Standard Deviation 0.02	1.9 nmol/g Standard Deviation 0.7	1.5 nmol/g Standard Deviation 1.8	2.5 nmol/g Standard Deviation 3.0	0.03 nmol/g Standard Deviation 0.1

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Chandan K. Sen, PhD. Professor and Associate Dean

The Ohio State University Wexner Medical Center

Phone: 614-247-7658

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place