- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00067899
Oxidative Stress and Vitamin E Requirements
June 17, 2013 updated by: Maret Traber, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
99
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oregon
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Corvallis, Oregon, United States, 97331
- Linus Pauling Institute - Oregon State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Traber MG, Winklhofer-Roob BM, Roob JM, Khoschsorur G, Aigner R, Cross C, Ramakrishnan R, Brigelius-Flohe R. Vitamin E kinetics in smokers and nonsmokers. Free Radic Biol Med. 2001 Dec 1;31(11):1368-74. doi: 10.1016/s0891-5849(01)00723-7.
- 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. doi: 10.1093/ajcn/77.1.160.
- 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. doi: 10.1016/s0272-5231(05)70016-2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2000
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
August 29, 2003
First Submitted That Met QC Criteria
September 5, 2003
First Posted (Estimate)
September 8, 2003
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 17, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSVER (completed)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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