Chronic Obstructive Pulmonary DiseasePhase 3NCT00063453
Supplemental Selenium and Vitamin E and Pulmonary Function
A Phase 3 study testing Vitamin E and Selenium in people with Chronic Obstructive Pulmonary Disease and Lung Diseases, run by Cornell University.
Trial summary
To test whether supplementation with selenium and/or vitamin E affects pulmonary function. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Lung Diseases, Lung Diseases, Obstructive
- What is being tested?
- Vitamin E and Selenium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,920 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Aug 2010
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Off both SELECT supplements
About this study
Official title: The Respiratory Ancillary Study (RAS) to SELECT
To test whether supplementation with selenium and/or vitamin E affects pulmonary function.
Read the detailed description
BACKGROUND:
There is compelling evidence from observational epidemiologic studies that intakes of nutrients with antioxidant properties are associated with reduced risks of chronic obstructive disease (COPD) and increased lung function. This study is ancillary to the multisite Selenium and Vitamin E Cancer Prevention Trial (SELECT), a 4-arm placebo-controlled, double-blinded randomized trial in 35,000 men testing whether daily supplementation with vitamin E (400mg alpha-tocopherol), selenium (200 micrograms selenomethionine) or both vitamin E and selenium can prevent prostate cancer.
DESIGN NARRATIVE:
This study is ancillary to the multisite Selenium and Vitamin E Cancer Prevention Trial (SELECT), a 4-arm placebo-controlled, double-blinded randomized trial in 35,000 men testing whether daily supplementation with vitamin E (400mg alpha-tocopherol), selenium (200 micrograms selenomethionine) or both vitamin E and selenium can prevent prostate cancer. A total of 3,000 SELECT participants will be enrolled for this respiratory ancillary study, and data collection will be extended to include pulmonary function, respiratory disease, and respiratory symptoms. Biological measures of nutrient exposure (serum vitamin E and selenium) and plasma lipids (total and high-density lipoprotein cholesterol) will be collected on all participants and oxidant burden (urinary F2-isoprostane) on a sub sample of heavy smokers and men with COPD. The primary outcome will be change over about 36 months in forced expiratory volume in the first second (FEV1). FEV1 is a valid and reliable measure of respiratory function that strongly predicts COPD and mortality. Extensive data on diet and dietary supplement use are being collected by the SELECT parent study. All specific aims examine pre-specified contrasts between the 4 arms of the SELECT randomized trial. The underlying hypothesis is that supplements will reduce the age related decline in FEV1 and thus at the 3-year follow-up FEV1, which will be tested in longitudinal and cross-sectional models. A secondary aim considers whether the effect of supplementation is greater among smokers (high burden of exogenous oxidants) who, by purposive selection of the study sites, will comprise about 25% of the sample.
- Being tested
- Vitamin E, Selenium, Vitamin E placebo, Selenium placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDietary supplement
Also called all rac-α-tocopheryl acetate
vitamin E (400 IU/day all rac-α-tocopheryl acetate)
SeleniumDietary supplement
Also called L-selenomethionine
selenium (200 μg/d L-selenomethionine)
Vitamin E placeboDietary supplement
Also called Placebo
placebo
Selenium placeboDietary supplement
Also called placebo
placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E and selenium placebo | Experimental | Vitamin E alone Receives: Dietary Supplement: Vitamin E; Dietary Supplement: Selenium placebo |
| Selenium and vitamin E placebo | Experimental | Selenium alone Receives: Dietary Supplement: Selenium; Dietary Supplement: Vitamin E placebo |
| Vitamin E and selenium | Experimental | Vitamin E and selenium combined Receives: Dietary Supplement: Vitamin E; Dietary Supplement: Selenium |
| vitamin E Placebo and Selenium placebo | Placebo comparator | Double placebo Receives: Dietary Supplement: Vitamin E placebo; Dietary Supplement: Selenium placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary function over time by arm of study
Measured: Outcome is assessed at annual and bi-annual study visits, during in-person visit of participant to the study site. Over a period of about 36 to 48 months, participants are assessed between 3 and 4 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2003 (estimated)
- Study startAug 2003
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Patricia A. Cassano, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063453
- Sponsor's protocol ID
- 151
- Other IDs
- R01HL071022
- Status last verified
- Dec 2017
- First submitted
- 26 Jun 2003
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.
PubMed 27519183Guertin KA, Grant RK, Arnold KB, Burwell L, Hartline J, Goodman PJ, Minasian LM, Lippman SM, Klein E, Cassano PA. Effect of long-term vitamin E and selenium supplementation on urine F2-isoprostanes, a biomarker of oxidative stress. Free Radic Biol Med. 2016 Jun;95:349-56. doi: 10.1016/j.freeradbiomed.2016.03.010. Epub 2016 Mar 22.
PubMed 27012420Cassano PA, Guertin KA, Kristal AR, Ritchie KE, Bertoia ML, Arnold KB, Crowley JJ, Hartline J, Goodman PJ, Tangen CM, Minasian LM, Lippman SM, Klein E. A randomized controlled trial of vitamin E and selenium on rate of decline in lung function. Respir Res. 2015 Mar 11;16(1):35. doi: 10.1186/s12931-015-0195-5.
PubMed 25889509
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Respiratory Ancillary Study (RAS) to SELECT
- ClinicalTrials.gov ID
- NCT00063453
- Acronym / sponsor ID
- 151
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,920 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2003
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Jun 2003 (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.
To test whether supplementation with selenium and/or vitamin E affects pulmonary function.
Detailed description
BACKGROUND:
There is compelling evidence from observational epidemiologic studies that intakes of nutrients with antioxidant properties are associated with reduced risks of chronic obstructive disease (COPD) and increased lung function. This study is ancillary to the multisite Selenium and Vitamin E Cancer Prevention Trial (SELECT), a 4-arm placebo-controlled, double-blinded randomized trial in 35,000 men testing whether daily supplementation with vitamin E (400mg alpha-tocopherol), selenium (200 micrograms selenomethionine) or both vitamin E and selenium can prevent prostate cancer.
DESIGN NARRATIVE:
This study is ancillary to the multisite Selenium and Vitamin E Cancer Prevention Trial (SELECT), a 4-arm placebo-controlled, double-blinded randomized trial in 35,000 men testing whether daily supplementation with vitamin E (400mg alpha-tocopherol), selenium (200 micrograms selenomethionine) or both vitamin E and selenium can prevent prostate cancer. A total of 3,000 SELECT participants will be enrolled for this respiratory ancillary study, and data collection will be extended to include pulmonary function, respiratory disease, and respiratory symptoms. Biological measures of nutrient exposure (serum vitamin E and selenium) and plasma lipids (total and high-density lipoprotein cholesterol) will be collected on all participants and oxidant burden (urinary F2-isoprostane) on a sub sample of heavy smokers and men with COPD. The primary outcome will be change over about 36 months in forced expiratory volume in the first second (FEV1). FEV1 is a valid and reliable measure of respiratory function that strongly predicts COPD and mortality. Extensive data on diet and dietary supplement use are being collected by the SELECT parent study. All specific aims examine pre-specified contrasts between the 4 arms of the SELECT randomized trial. The underlying hypothesis is that supplements will reduce the age related decline in FEV1 and thus at the 3-year follow-up FEV1, which will be tested in longitudinal and cross-sectional models. A secondary aim considers whether the effect of supplementation is greater among smokers (high burden of exogenous oxidants) who, by purposive selection of the study sites, will comprise about 25% of the sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin E and selenium placebo | Experimental | Dietary Supplement: Vitamin E, Dietary Supplement: Selenium placeboVitamin E alone |
| Selenium and vitamin E placebo | Experimental | Dietary Supplement: Selenium, Dietary Supplement: Vitamin E placeboSelenium alone |
| Vitamin E and selenium | Experimental | Dietary Supplement: Vitamin E, Dietary Supplement: SeleniumVitamin E and selenium combined |
| vitamin E Placebo and Selenium placebo | Placebo comparator | Dietary Supplement: Vitamin E placebo, Dietary Supplement: Selenium placeboDouble placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Off both SELECT supplements
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 |
|---|---|---|
| Vitamin EAlso: all rac-α-tocopheryl acetatevitamin E (400 IU/day all rac-α-tocopheryl acetate) | Dietary supplement | Vitamin E and selenium, Vitamin E and selenium placebo |
| SeleniumAlso: L-selenomethionineselenium (200 μg/d L-selenomethionine) | Dietary supplement | Selenium and vitamin E placebo, Vitamin E and selenium |
| Vitamin E placeboAlso: Placeboplacebo | Dietary supplement | Selenium and vitamin E placebo, vitamin E Placebo and Selenium placebo |
| Selenium placeboAlso: placeboplacebo | Dietary supplement | Vitamin E and selenium placebo, vitamin E Placebo and Selenium placebo |
Primary outcome
Change in pulmonary function over time by arm of study
Time frame: Outcome is assessed at annual and bi-annual study visits, during in-person visit of participant to the study site. Over a period of about 36 to 48 months, participants are assessed between 3 and 4 times
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 12 Dec 2017.
- Derived from this study: PubMed 27519183Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.
- Derived from this study: PubMed 27012420Guertin KA, Grant RK, Arnold KB, Burwell L, Hartline J, Goodman PJ, Minasian LM, Lippman SM, Klein E, Cassano PA. Effect of long-term vitamin E and selenium supplementation on urine F2-isoprostanes, a biomarker of oxidative stress. Free Radic Biol Med. 2016 Jun;95:349-56. doi: 10.1016/j.freeradbiomed.2016.03.010. Epub 2016 Mar 22.
- Derived from this study: PubMed 25889509Cassano PA, Guertin KA, Kristal AR, Ritchie KE, Bertoia ML, Arnold KB, Crowley JJ, Hartline J, Goodman PJ, Tangen CM, Minasian LM, Lippman SM, Klein E. A randomized controlled trial of vitamin E and selenium on rate of decline in lung function. Respir Res. 2015 Mar 11;16(1):35. doi: 10.1186/s12931-015-0195-5.
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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.
Patricia A. Cassano, PhD principal investigator
Cornell University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin E and Selenium in people with Chronic Obstructive Pulmonary Disease and Lung Diseases, run by Cornell University.
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 0 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Change in pulmonary function over time by arm of study (time frame: Outcome is assessed at annual and bi-annual study visits, during in-person visit of participant to the study site. Over a period of about 36 to 48 months, participants are assessed between 3 and 4 times). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00063453, which also lists 3 linked publications.
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 12 Dec 2017.