Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

NCT00678834 | Completed Early Phase 1 Results DMC

• 1 other identifier: 2005C0034
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 such as skin, heart, lung, liver, adipose tissue, Brain and cerebrospinal fluid (CSF) following oral supplementation

Conditions

End Stage Cardiac Failure; Pulmonary Failure; End Stage Liver Disease; Morbid Obesity; Recalcitrant Epilepsy Requiring Surgery; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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)

  After at least 1 month of supplementation

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

To surgery patients, Tocotrienol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Dietary Supplement: To surgery patients, Tocotrienol capsules.

Arm 2

ACTIVE COMPARATOR

To surgery patients, Tocopherol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Dietary Supplement: To surgery patients, Tocopherol capsules.

Arm 3

ACTIVE COMPARATOR

Tocotrienol to healthy subjects - 200 mg to take orally two times a day (400 mg a day).

Dietary Supplement: Tocotrienol to healthy subjects.

Interventions

To surgery patients, Tocopherol capsules. DIETARY_SUPPLEMENT

200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Arm 2

Tocotrienol to healthy subjects. DIETARY_SUPPLEMENT

200 mg to take orally two times a day (400 mg a day).

Arm 3

To surgery patients, Tocotrienol capsules. DIETARY_SUPPLEMENT

200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Arm 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Chandan K Sen: lead
• Carotech Inc.: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43211, United States

Location

Related Publications (1)

• Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.

  PMID: 22298568 RESULT

MeSH Terms

Conditions

End Stage Liver Disease; Obesity, Morbid

Interventions

Tocopherols; Tocotrienols

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Chandan K. Sen, PhD. Professor and Associate Dean
• Organization: The Ohio State University Wexner Medical Center

chandan.sen@osumc.edu

614-247-7658

Study Officials

• Chandan Sen, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: March 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 16, 2014
• Results First Posted: September 16, 2014

Record last verified: 2014-07

Locations

US (1)