- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00046306
Nevada Environmental Tobacco Smoke and Health Study
Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study is designed to test whether exposure to ETS in the workplace effects a person's risk of developing chronic diseases such as cardiovascular disease and cancer. The second part of this study is designed to test whether antioxidant supplementation in this group of ETS exposed individuals can reduce their risk of developing chronic disease.
The study will look at 375 non-smokers who either work on a casino floor or as bartenders or cocktail servers. Initial baseline data will be collected (questionnaires and blood samples taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant supplementation and high antioxidant supplementation. They will be followed over a two-year period, coming in for follow-up testing every six months. Statistical analysis will be conducted to see whether this group of ETS exposed individuals has a greater risk of developing chronic disease and whether the use of antioxidant supplements can moderate any risks.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Nevada
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Las Vegas, Nevada, United States, 89102
- ETS Clinic, University of Nevada, School of Medicine, 1707 W. Charleston Blvd Suite 100
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Non-smoker Work in a casino - on the casino floor or work as a bartender or cocktail server for at least 1 year Do not take antioxidant supplements Healthy - not diagnosed with any major chronic diseases.
Exclusion Criteria:
Blood pressure SBP>200,<85 DBP>100, <40 Pulse >120, <45 Cholesterol >400 Triglycerides >700 Blood Cotinine >10 ng/ml BMI >35
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Collaborators and Investigators
Investigators
- Principal Investigator: Chris A Pritsos, Ph.D., University of Nevada, Reno
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9520-CP-001
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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