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
  Purpose

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.


Condition Intervention
Cancer
Prostate Cancer
Colorectal Cancer
Cardiovascular Disease
Eye Disease
Cognitive Decline
Dietary Supplement: Vitamin E
Dietary Supplement: Vitamin C
Dietary Supplement: Multivitamin
Dietary Supplement: Beta-carotene

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14641
Study Start Date: July 1997
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270647

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: J. Michael Gaziano, MD, MPH Brigham and Women's Hospital
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Michael Gaziano, MD, Physician, Brigham and Women's Hospital; Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00270647     History of Changes
Other Study ID Numbers: CDR0000448630, BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405, R01CA097193
Study First Received: December 27, 2005
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
cancer
prostate cancer
colorectal cancer
cardiovascular disease
eye disease
cognitive decline

Additional relevant MeSH terms:
Prostatic Neoplasms
Colorectal Neoplasms
Cardiovascular Diseases
Eye Diseases
Cognition Disorders
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Vitamins
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Ascorbic Acid
Beta Carotene
Carotenoids
Micronutrients

ClinicalTrials.gov processed this record on October 19, 2014