Oxidative Stress and Vitamin E Requirements

NCT00067899 | Completed Phase 2

• 1 other identifier: OSVER (completed)
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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 vitamin E metabolite in the urine.

Conditions

Smoking

Keywords

cigarette smoking; tocopherol; bioavailability; metabolism; oxidative stress

Interventions

Vitamin E with and without Vitamin C DRUG

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-smoking status or smokers (more than 1 pack per day)
• age: 18-35 y
• stable body weight, ranging between 80% and 130%,
• maintenance of normal exercise and activity patterns
• total cholesterol ≤ 7.758 mmol/L (300 mg/dl)
• triglyceride concentration ≤ 3.387 mmol/L (300 mg/dl)
• Subjects will be excluded if they fulfill any one of the following:
• antioxidant supplement users
• resting blood pressure above 160/105 mm Hg
• engaged in aerobic activity more than five hours per week
• vegetarian or other restrictive dietary requirements
• fasting blood glucose concentration of ≥ 7.77 mmol/L (140 mg/dl)
• history of diabetes or uremia
• other known metabolic disease or medication use known to affect lipid metabolism

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Linus Pauling Institute - Oregon State University

Corvallis, Oregon, 97331, United States

Location

Related Publications (3)

• 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. doi: 10.1016/s0891-5849(01)00723-7.

  PMID: 11728808 BACKGROUND

• 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. doi: 10.1093/ajcn/77.1.160.

  PMID: 12499336 BACKGROUND

• 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. doi: 10.1016/s0272-5231(05)70016-2.

  PMID: 10763098 BACKGROUND

MeSH Terms

Conditions

Smoking; Cigarette Smoking

Interventions

Vitamin E; Ascorbic Acid

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2003
• First Posted: September 8, 2003
• Study Start: September 1, 2000
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)