Oxidative Stress and Vitamin E Requirements

This study has been completed.

First Received on August 29, 2003. Last Updated on March 15, 2011 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00067899

Purpose

The purpose of this study is to determine if oxidative stress derived from cigarette smoking increases vitamin E requirements. The study will also assess the role of vitamin C in modulating vitamin E requirements. Vitamin E requirements will be assessed by measuring vitamin E in plasma as well as by measuring the excreted metabolite in the urine.

Condition	Intervention	Phase
Smoking	Drug: Vitamin E with and without Vitamin C	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Smoking Vitamin C Vitamin E

Drug Information available for: Ascorbic acid alpha-Tocopherol DL-alpha-Tocopherol Vitamin E Tocopherols Tocotrienol

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:	99
Study Start Date:	September 2000

Detailed Description:

We will be investigating the fractional disappearance rate of tocopherols in cigarette smokers compared to nonsmokers. This will be accomplished by supplementing individuals with deuterium labeled alpha- and gamma-tocopherols. Quantification of plasma tocopherols as well as urinary metabolites, alpha- and gamma-CEHC, will be determined using LC/MS analysis. In addition, the role of vitamin C as it pertains to its influence on the fraction disappearance rate of vitamin E will also be evaluated.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Nonsmokers and Smokers (>10 cigarettes)
Non-nutritional supplement user
Free of disease
Total cholesterol < 240 mg/dl
Triglycerides < 200 mg/dl
< 5hrs/week of aerobic exercise

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067899

Locations

United States, Oregon
Linus Pauling Institute - Oregon State University
Corvallis, Oregon, United States, 97331

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Publications:

Traber MG, Winklhofer-Roob BM, Roob JM, Khoschsorur G, Aigner R, Cross C, Ramakrishnan R, Brigelius-Flohe R. Vitamin E kinetics in smokers and nonsmokers. Free Radic Biol Med. 2001 Dec 1;31(11):1368-74.

Dietrich M, Block G, Norkus EP, Hudes M, Traber MG, Cross CE, Packer L. Smoking and exposure to environmental tobacco smoke decrease some plasma antioxidants and increase gamma-tocopherol in vivo after adjustment for dietary antioxidant intakes. Am J Clin Nutr. 2003 Jan;77(1):160-6.

Traber MG, van der Vliet A, Reznick AZ, Cross CE. Tobacco-related diseases. Is there a role for antioxidant micronutrient supplementation? Clin Chest Med. 2000 Mar;21(1):173-87, x. Review.

ClinicalTrials.gov Identifier:	NCT00067899 History of Changes
Other Study ID Numbers:	OSVER (completed)
Study First Received:	August 29, 2003
Last Updated:	March 15, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

cigarette smoking
tocopherol
bioavailability
metabolism
oxidative stress

Additional relevant MeSH terms:

Smoking
Habits
Ascorbic Acid
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins

Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012