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Oxidative Stress and Vitamin E Requirements

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00067899
First Posted: September 8, 2003
Last Update Posted: June 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maret Traber, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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 vitamin E metabolite in the urine.

Condition Intervention Phase
Smoking Drug: Vitamin E with and without Vitamin C Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Oxidative Stress and Vitamin E Requirements

Resource links provided by NLM:


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

Estimated Enrollment: 99
Study Start Date: September 2000
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.
  Eligibility

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
Criteria

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


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:
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 Submitted: August 29, 2003
First Posted: September 8, 2003
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
tocopherol
bioavailability
metabolism
oxidative stress

Additional relevant MeSH terms:
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents