Oxidative Stress and Vitamin E Requirements

Smoking Clinical Trial

Official title:

Oxidative Stress and Vitamin E Requirements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067899
• Other study ID #: OSVER (completed)
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2003
• Last updated: June 17, 2013
• Start date: September 2000
• Est. completion date: December 2005

Study information

• Verified date: June 2013
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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-carboxy ethyl hydroxychromanol, will be determined using liquid chromatography/mass spectrometry 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Vitamin E with and without Vitamin C

Locations

Country	Name	City	State
United States	Linus Pauling Institute - Oregon State University	Corvallis	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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