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| Sponsored by: |
National Institute of Environmental Health Sciences (NIEHS) |
| Information provided by: | National Institute of Environmental Health Sciences (NIEHS) |
| ClinicalTrials.gov Identifier: | NCT00046306 |
Purpose
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.
| Condition | Intervention | Phase |
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Cardiovascular Disease Cancer |
Drug: Antioxidants |
Phase III |
| Genetics Home Reference related topics: | Benign Tumors Cancer Heart Diseases Vascular Diseases |
| MedlinePlus related topics: | Antioxidants Cancer Coping with Chronic Illness Smoking |
| ChemIDplus related topics: | Attapulgite Bismuth subsalicylate Kaopectate |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
Eligibility
| Ages Eligible for Study: | 22 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Nevada | |||||
| ETS Clinic, University of Nevada, School of Medicine, 1707 W. Charleston Blvd Suite 100 | |||||
| Las Vegas, Nevada, United States, 89102 | |||||
| Principal Investigator: | Chris A Pritsos, Ph.D. | University of Nevada, Reno |
More Information
| Study ID Numbers: | 9520-CP-001 |
| First Received: | September 26, 2002 |
| Last Updated: | March 22, 2006 |
| ClinicalTrials.gov Identifier: | NCT00046306 |
| Health Authority: | United States: Federal Government |
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