NCT00063453

Brief Summary

To test whether supplementation with selenium and/or vitamin E affects pulmonary function.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,920

participants targeted

Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

7 years

First QC Date

June 26, 2003

Last Update Submit

December 8, 2017

Conditions

Chronic Obstructive Pulmonary DiseaseLung DiseasesLung Diseases, Obstructive

Outcome Measures

Primary Outcomes (1)

  • Change in pulmonary function over time by arm of study

    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

Other Outcomes (1)

  • Effect of selenium and vitamin E supplementation on incidence of COPD

    Questionnaire data on incident lung disease is assessed at annual and biannual study visits, in all SELECT participants. These questionnaire data were collected through the end of SELECT active follow-up, which was December 2010

Study Arms (4)

Vitamin E and selenium placebo

EXPERIMENTAL

Vitamin E alone

Dietary Supplement: Vitamin EDietary Supplement: Selenium placebo

Selenium and vitamin E placebo

EXPERIMENTAL

Selenium alone

Dietary Supplement: SeleniumDietary Supplement: Vitamin E placebo

Vitamin E and selenium

EXPERIMENTAL

Vitamin E and selenium combined

Dietary Supplement: Vitamin EDietary Supplement: Selenium

vitamin E Placebo and Selenium placebo

PLACEBO COMPARATOR

Double placebo

Dietary Supplement: Vitamin E placeboDietary Supplement: Selenium placebo

Interventions

Vitamin EDIETARY_SUPPLEMENT

vitamin E (400 IU/day all rac-α-tocopheryl acetate)

Also known as: all rac-α-tocopheryl acetate
Vitamin E and seleniumVitamin E and selenium placebo
SeleniumDIETARY_SUPPLEMENT

selenium (200 μg/d L-selenomethionine)

Also known as: L-selenomethionine
Selenium and vitamin E placeboVitamin E and selenium
Vitamin E placeboDIETARY_SUPPLEMENT

placebo

Also known as: Placebo
Selenium and vitamin E placebovitamin E Placebo and Selenium placebo
Selenium placeboDIETARY_SUPPLEMENT

placebo

Also known as: placebo
Vitamin E and selenium placebovitamin E Placebo and Selenium placebo

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Off both SELECT supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 27519183DERIVED

  • Guertin 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.

    PMID: 27012420DERIVED

  • Cassano 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.

    PMID: 25889509DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung DiseasesLung Diseases, Obstructive

Interventions

Vitamin ESelenium

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Patricia A. Cassano, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2003

First Posted

June 30, 2003

Study Start

August 1, 2003

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 12, 2017

Record last verified: 2017-12