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OpenTrials
Completed

NCT Number: NCT00067899

Oxidative Stress and Vitamin E Requirements

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.

Completed

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Linus Pauling Institute - Oregon State University

Corvallis, Oregon, 97331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E with and without Vitamin C

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Sep 8, 2003
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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