NCT00784225

Brief Summary

RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent cataracts or age-related macular degeneration in men receiving these drugs as part of a clinical trial for the prevention of prostate cancer. PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work in preventing cataract and age-related macular degeneration in men enrolled on SELECT (SWOG-S0000).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,475

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2004

Longer than 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 23, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

13.3 years

First QC Date

October 31, 2008

Results QC Date

May 10, 2019

Last Update Submit

August 2, 2019

Conditions

CataractMacular Degeneration

Keywords

cataractadvanced macular degeneration

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)

    Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30)

    Every 6 months, up to 7 years

  • Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30

    Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity.

    Every 6 months, up to 7 years

Secondary Outcomes (2)

  • Number of Participants With Advanced AMD

    Every 6 months, up to 7 years

  • Number of Participants Who Underwent Cataract Extraction

    Every 6 months, up to 7 years

Study Arms (4)

Vitamin E + selenium placebo

EXPERIMENTAL

vitamin E and selenium placebo daily for 7-12 years

Drug: vitamin EDrug: selenium placebo

Selenium + vitamin E placebo

EXPERIMENTAL

selenium and vitamin E placebo daily for 7-12 years

Drug: seleniumDrug: vitamin E placeboDrug: selenium placebo

Vitamin E + selenium

EXPERIMENTAL

vitamin E and selenium placebo daily for 7-12 years

Drug: seleniumDrug: vitamin E

Vitamin E placebo + selenium placebo

PLACEBO COMPARATOR

vitamin E placebo and selenium placebo daily for 7-12 years

Drug: vitamin E placeboDrug: selenium placebo

Interventions

seleniumDRUG

200 mcg daily for 7-12 years

Also known as: L-selenomethionine
Selenium + vitamin E placeboVitamin E + selenium
vitamin EDRUG

400 IU daily by mouth for 7-12 years

Also known as: alpha tocopherol
Vitamin E + seleniumVitamin E + selenium placebo
vitamin E placeboDRUG

daily for 7-12 years

Also known as: placebo
Selenium + vitamin E placeboVitamin E placebo + selenium placebo
selenium placeboDRUG

daily for 7-12 years

Also known as: placebo
Selenium + vitamin E placeboVitamin E + selenium placeboVitamin E placebo + selenium placebo

Eligibility Criteria

Age50 Years - 120 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT) SWOG-S0000 * Diagnosis of 1 of the following: * Age-related macular degeneration (AMD) at baseline or at follow-up * Cataract or a cataract extraction at follow-up (Closed for accrual as of 10/01/29) * Participants with a prior diagnosis of cataract at baseline followed by another cataract event (cataract diagnosis or a cataract extraction) at follow-up are not eligible * Participants with a prior diagnosis of cataract at baseline followed by a diagnosis of AMD at follow-up are eligible PATIENT CHARACTERISTICS: * See Disease Characteristics PRIOR CONCURRENT THERAPY: * Not applicable

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • 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

  • Christen WG, Glynn RJ, Gaziano JM, Darke AK, Crowley JJ, Goodman PJ, Lippman SM, Lad TE, Bearden JD, Goodman GE, Minasian LM, Thompson IM Jr, Blanke CD, Klein EA. Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):17-24. doi: 10.1001/jamaophthalmol.2014.3478.

    PMID: 25232809DERIVED

MeSH Terms

Conditions

CataractMacular Degeneration

Interventions

SeleniumVitamin Ealpha-Tocopherol

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRetinal DegenerationRetinal Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTocopherols

Results Point of Contact

Title
SELECT/S0000B Statistician
Organization
SWOG Statistical Center
adarke@fredhutch.org
2066674623

Study Officials

  • William Christen, ScD

    Dana-Farber/Brigham and Women's Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

July 1, 2004

Primary Completion

November 1, 2017

Study Completion

May 1, 2018

Last Updated

August 14, 2019

Results First Posted

July 23, 2019

Record last verified: 2019-08

Locations

US(1)