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S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000

NCT00784225 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13475

Last updated 2019-08-14

Study results available
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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).

Conditions

  • Cataract
  • Macular Degeneration

Interventions

DRUG

selenium

200 mcg daily for 7-12 years

DRUG

vitamin E

400 IU daily by mouth for 7-12 years

DRUG

vitamin E placebo

daily for 7-12 years

DRUG

selenium placebo

daily for 7-12 years

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Eye Institute (NEI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • William Christen, ScD · Dana-Farber/Brigham and Women's Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2017-11-30
Completion
2018-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00784225 on ClinicalTrials.gov