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Physicians' Health Study II (PHS II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00270647
Recruitment Status : Completed
First Posted : December 28, 2005
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Michael Gaziano, MD, Brigham and Women's Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14641 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease
Study Start Date : July 1997
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Prostate cancer [ Time Frame: Ongoing ]
  2. Total cancer [ Time Frame: Ongoing ]
  3. Major cardiovascular events [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. Cataract [ Time Frame: Ongoing ]
  2. Age-related macular degeneration [ Time Frame: Ongoing ]
  3. Early cognitive decline [ Time Frame: Ongoing ]
  4. Myocardial infarction [ Time Frame: Ongoing ]
  5. Stroke [ Time Frame: Ongoing ]
  6. Colorectal cancer [ Time Frame: Ongoing ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270647


Sponsors and Collaborators
Brigham and Women's Hospital
National Cancer Institute (NCI)
Investigators
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Principal Investigator: J. Michael Gaziano, MD, MPH Brigham and Women's Hospital
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    
Other Study ID Numbers: CDR0000448630
BWH-1999-P-003315
BWH-1999-P-003318
BWH-83-00405
R01CA097193 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by John Michael Gaziano, MD, Brigham and Women's Hospital:
cancer
prostate cancer
colorectal cancer
 cardiovascular disease
eye disease
cognitive decline
Additional relevant MeSH terms:
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Prostatic Neoplasms
Colorectal Neoplasms
Eye Diseases
Cardiovascular Diseases
Cognitive Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Vitamins
Vitamin E
Beta Carotene
Carotenoids
Micronutrients