Physicians' Health Study II (PHS II)

February 26, 2018 updated by: John Michael Gaziano, MD, Brigham and Women's Hospital

Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

14641

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin E
Active or placebo vitamin E
Dietary supplement: Vitamin E
400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)
Experimental: Vitamin C
Active or placebo vitamin C
Dietary supplement: Vitamin C
500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)
Experimental: Multivitamin
Active or placebo multivitamin
Dietary supplement: Multivitamin
Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
Experimental: Beta-carotene
Active or placebo beta-carotene
Dietary supplement: Beta-carotene
50 mg Lurotin or placebo on alternate days (provided by BASF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prostate cancer
Time Frame: Ongoing
Ongoing
Total cancer
Time Frame: Ongoing
Ongoing
Major cardiovascular events
Time Frame: Ongoing
Ongoing

Secondary Outcome Measures

Outcome Measure
Time Frame
Cataract
Time Frame: Ongoing
Ongoing
Age-related macular degeneration
Time Frame: Ongoing
Ongoing
Early cognitive decline
Time Frame: Ongoing
Ongoing
Myocardial infarction
Time Frame: Ongoing
Ongoing
Stroke
Time Frame: Ongoing
Ongoing
Colorectal cancer
Time Frame: Ongoing
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: J. Michael Gaziano, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1997

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 27, 2005

First Submitted That Met QC Criteria

December 27, 2005

First Posted (Estimate)

December 28, 2005

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000448630
  • BWH-1999-P-003315
  • BWH-1999-P-003318
  • BWH-83-00405
  • R01CA097193 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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