Status:
COMPLETED
Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
Lead Sponsor:
Chandan K Sen
Collaborating Sponsors:
Carotech Inc.
Conditions:
End Stage Cardiac Failure
Pulmonary Failure
Eligibility:
All Genders
21+ years
Phase:
EARLY_PHASE1
Brief Summary
Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues s...
Detailed Description
In nature, there are eight members in the vitamin E family: a-, b-, g- and d-TCP, and a-, b-, g- and d-tocotrienol (TCT). Vitamin E research has developed highly asymmetrically. Out of the 25,000+ pap...
Eligibility Criteria
Inclusion
- Aim 1 Surgical candidate with a surgery schedule date with a time period of 4-24 weeks (\<4 weeks will be excluded; last dose until 24h before surgery) In Aim 1 we expect to have patients, with diverse co-morbidity and medication conditions.
- Patient Selection: Because of limitation in obtaining healthy human tissues (as in Aim 2), we plan to obtain these tissues from patients who are scheduled for the following surgeries for subjects in group one:
- Heart Heart Transplant Heart Failure- Biopsy taken from diseased heart Lung Lung Transplant, Lung-wedge/resection, Lobectomy Cancer- Tissue sample taken from removed lung or resected portion of lung Liver Liver Transplant, Biopsy, Resection Hepatic Malignancy- Biopsy taken from resected portion of liver Adipose Tissue Panniculectomy Excessive Tissue of the Abdomen Brain \& CSF Epilepsy Excised brain tissue and cerebrospinal fluid
- To ensure higher enrollment we are not controlling for age of subjects as long as the subjects are 21 years of age or older.
- Inclusion Criteria Aim 1:
- age 21 and older
- good health
- non- smoker
- no current medications
- non- pregnant or non-breastfeeding
- no previous use of OTC medications or other form of supplements containing vitamin-E.
- Inclusion Criteria Aim 2:
- age 21 - 40 years
- good health
- non- smoker
- no current medications
- non- pregnant or non-breastfeeding
- no previous use of OTC medications or other form of supplements containing vitamin-E.
- Exclusion Criteria Aim 1:
- Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements
- Scheduled surgery date lesser than 4 weeks or greater than 24 weeks.
- Exclusion Criteria Aim 2:
- Over 40 or under 21 years of age
- Current smoker
- Pregnant and breastfeeding
- Diabetes and HIV diagnosis
- Immunosuppression therapy
- Any neurological problems
- Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements
- ETOH or drug abuse
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00678834
Start Date
March 1 2006
End Date
June 1 2012
Last Update
September 16 2014
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43211