NCT00046306

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

First QC Date

September 26, 2002

Last Update Submit

January 11, 2013

Conditions

Cardiovascular DiseaseCancer

Keywords

Oxidative StressCardiovascular DiseaseCancer

Interventions

AntioxidantsDRUG

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Blood pressure SBP\>200,\<85 DBP\>100, \<40 Pulse \>120, \<45 Cholesterol \>400 Triglycerides \>700 Blood Cotinine \>10 ng/ml BMI \>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETS Clinic, University of Nevada, School of Medicine, 1707 W. Charleston Blvd Suite 100

Las Vegas, Nevada, 89102, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesNeoplasms

Interventions

Antioxidants

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Study Officials

  • Chris A Pritsos, Ph.D.

    University of Nevada, Reno

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 26, 2002

First Posted

September 30, 2002

Study Completion

August 1, 2005

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

US(1)