Cardiovascular DiseasePhase 3NCT00046306
Nevada Environmental Tobacco Smoke and Health Study
A Phase 3 study testing Antioxidants in people with Cardiovascular Disease and Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Cancer
- What is being tested?
- Antioxidants
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Blood pressure SBP>200,<85 DBP>100, <40 Pulse >120, <45 Cholesterol >400 Triglycerides >700 Blood Cotinine >10 ng/ml BMI >35
Trial locations and contacts
1 site in 1 country.
United States1 site
ETS Clinic, University of Nevada, School of Medicine, 1707 W. Charleston Blvd Suite 100
Las Vegas, Nevada, 89102
About this 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.
- Conditions
- Cardiovascular Disease, Cancer
- Being tested
- Antioxidants
- Keywords
- Oxidative Stress, Cardiovascular Disease, Cancer
- Medical subject headings
- Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2002 (estimated)
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 375 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Chris A Pritsos, Ph.D., Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046306
- Sponsor's protocol ID
- 9520-CP-001
- Status last verified
- Jan 2013
- First submitted
- 26 Sep 2002
- Last updated
- 14 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nevada Environmental Tobacco Smoke and Health Study
- ClinicalTrials.gov ID
- NCT00046306
- Acronym / sponsor ID
- 9520-CP-001
- Conditions
- Cardiovascular Disease, Cancer
- Keywords
- Oxidative Stress, Cardiovascular Disease, Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study completion
- Aug 2005 (actual)
- First posted
- 30 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Blood pressure SBP>200,<85 DBP>100, <40 Pulse >120, <45 Cholesterol >400 Triglycerides >700 Blood Cotinine >10 ng/ml BMI >35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidants | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris A Pritsos, Ph.D. principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antioxidants in people with Cardiovascular Disease and Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.