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Oxidative Stress and Vitamin E Requirements

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ClinicalTrials.gov Identifier: NCT00067899
Recruitment Status : Completed
First Posted : September 8, 2003
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Smoking Drug: Vitamin E with and without Vitamin C Phase 2

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-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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Oxidative Stress and Vitamin E Requirements
Study Start Date : September 2000
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking Vitamin E
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067899

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

Responsible Party: Maret Traber, Professor, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00067899     History of Changes
Other Study ID Numbers: OSVER (completed)
First Posted: September 8, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Maret Traber, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
cigarette smoking
oxidative stress

Additional relevant MeSH terms:
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents