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Clinical Trials (PDQ®)

Physicians' Health Study II

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedPreventionCompleted50 and overNCI, OtherCDR0000448630
BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405, R01CA097193, NCT00270647

Trial Description

Summary

The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer, cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how well they work compared with placebos in preventing cancer, cardiovascular disease, eye disease, and cognitive decline in male doctors aged 50 years and older.

Further Study Information

OBJECTIVES:

Primary

  • To determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians.
  • To determine whether daily vitamin C and/or a multivitamin reduces the risk of total cancer in these participants.
  • To determine whether vitamin E every other day, vitamin C daily, or a multivitamin daily reduces the risk of major cardiovascular events in these participants.

Secondary

  • To determine whether vitamin E and/or multivitamins reduce the risk of developing total cancer, colon cancer, and colon polyps in these participants.
  • To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.
  • To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.
  • To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of early cognitive decline in participants aged 65 and over.

The Physicians' Health Study II was a randomized, double-blind, placebo-controlled, factorial trial that began in 1997 and ended in 2011. It was designed to test four supplements -- (1) alternate-day vitamin E (400 international units of synthetic alpha-tocopherol) or its placebo; (2) daily vitamin C (500 mg synthetic ascorbic acid) or its placebo; (3) a daily multivitamin (Centrum Silver) or its placebo; and (4) alternate-day beta carotene (50 mg Lurotin) or its placebo -- in the prevention of cancer, cardiovascular disease, eye disease, and early cognitive decline among 14,641 male physicians aged 50 years or older. Participants were randomly assigned in a 2x2x2x2 factorial trial to receive combinations of the four active supplements or their placebos. Pills and/or packaging were provided by BASF Corporation, Pfizer (formerly Wyeth, American Home Products, and Lederle), and DSM Nutritional Products (formerly Roche Vitamins).

The beta-carotene component was discontinued on March 8, 2003; the vitamin E and vitamin C components ended as scheduled on August 31, 2007; and the multivitamin component ended on June 1, 2011.

Eligibility Criteria

INCLUSION CRITERIA

1. DISEASE CHARACTERISTICS:

  • Healthy male physicians practicing in the United States
  • Prior participation in the Physicians' Health Study I allowed

2. PATIENT CHARACTERISTICS:

  • Aged 50 years and over
  • No history of serious illness that would preclude study participation
  • No history of significant adverse events (e.g., rash or allergic reaction) attributed to study agents

3. PRIOR CONCURRENT THERAPY:

  • No other concurrent vitamin and/or multivitamin supplementation
  • No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)

Trial Contact Information

Trial Lead Organizations/Sponsors

Dana-Farber/Brigham and Women's Cancer Center

National Cancer Institute

J. Michael Gaziano, MD, MPHPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00270647
ClinicalTrials.gov processed this data on October 20, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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