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Physicians' Health Study II (PHS II)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Michael Gaziano, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00270647
First received: December 27, 2005
Last updated: July 17, 2012
Last verified: July 2012

December 27, 2005
July 17, 2012
July 1997
June 2011   (final data collection date for primary outcome measure)
  • Prostate cancer [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Total cancer [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Major cardiovascular events [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00270647 on ClinicalTrials.gov Archive Site
  • Cataract [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Age-related macular degeneration [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Early cognitive decline [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Colorectal cancer [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Physicians' Health Study II
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Cardiovascular Disease
  • Eye Disease
  • Cognitive Decline
  • Dietary Supplement: Vitamin E
    400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)
  • Dietary Supplement: Vitamin C
    500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)
  • Dietary Supplement: Multivitamin
    Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
  • Dietary Supplement: Beta-carotene
    50 mg Lurotin or placebo on alternate days (provided by BASF)
  • Experimental: Vitamin E
    Active or placebo vitamin E
    Intervention: Dietary Supplement: Vitamin E
  • Experimental: Vitamin C
    Active or placebo vitamin C
    Intervention: Dietary Supplement: Vitamin C
  • Experimental: Multivitamin
    Active or placebo multivitamin
    Intervention: Dietary Supplement: Multivitamin
  • Experimental: Beta-carotene
    Active or placebo beta-carotene
    Intervention: Dietary Supplement: Beta-carotene

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14641
June 2011
June 2011   (final data collection date for primary outcome measure)

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)
Male
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00270647
CDR0000448630, BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405, R01CA097193
Yes
John Michael Gaziano, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
National Cancer Institute (NCI)
Principal Investigator: J. Michael Gaziano, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP