Oxidative Stress and Vitamin E Requirements

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maret Traber, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00067899
First received: August 29, 2003
Last updated: June 17, 2013
Last verified: June 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Oxidative Stress and Vitamin E Requirements

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
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
  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)
Study First Received: August 29, 2003
Last Updated: June 17, 2013
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 April 17, 2014