PHS II: Physicians' Health Study II
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
Primary
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To determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians.
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To determine whether daily vitamin C and/or a multivitamin reduces the risk of total cancer in these participants.
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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
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To determine whether vitamin E and/or multivitamins reduce the risk of developing total cancer, colon cancer, and colon polyps in these participants.
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To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.
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To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.
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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
Arms and Interventions
| 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
Primary Outcome Measures
- Prostate cancer [Ongoing]
- Total cancer [Ongoing]
- Major cardiovascular events [Ongoing]
Secondary Outcome Measures
- Cataract [Ongoing]
- Age-related macular degeneration [Ongoing]
- Early cognitive decline [Ongoing]
- Myocardial infarction [Ongoing]
- Stroke [Ongoing]
- Colorectal cancer [Ongoing]
Eligibility Criteria
Criteria
INCLUSION CRITERIA
- DISEASE CHARACTERISTICS:
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Healthy male physicians practicing in the United States
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Prior participation in the Physicians' Health Study I allowed
- PATIENT CHARACTERISTICS:
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Aged 50 years and over
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No history of serious illness that would preclude study participation
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No history of significant adverse events (e.g., rash or allergic reaction) attributed to study agents
- PRIOR CONCURRENT THERAPY:
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No other concurrent vitamin and/or multivitamin supplementation
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No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Brigham and Women's Hospital
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: J. Michael Gaziano, MD, MPH, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- CDR0000448630
- BWH-1999-P-003315
- BWH-1999-P-003318
- BWH-83-00405
- R01CA097193