Physicians' Health Study II (PHS II)
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|ClinicalTrials.gov Identifier: NCT00270647|
Recruitment Status : Completed
First Posted : December 28, 2005
Last Update Posted : February 28, 2018
|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|
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||14641 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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)
Active or placebo multivitamin
Dietary Supplement: Multivitamin
Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
Active or placebo beta-carotene
Dietary Supplement: Beta-carotene
50 mg Lurotin or placebo on alternate days (provided by BASF)
- Prostate cancer [ Time Frame: Ongoing ]
- Total cancer [ Time Frame: Ongoing ]
- Major cardiovascular events [ Time Frame: Ongoing ]
- Cataract [ Time Frame: Ongoing ]
- Age-related macular degeneration [ Time Frame: Ongoing ]
- Early cognitive decline [ Time Frame: Ongoing ]
- Myocardial infarction [ Time Frame: Ongoing ]
- Stroke [ Time Frame: Ongoing ]
- Colorectal cancer [ Time Frame: Ongoing ]
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
|Principal Investigator:||J. Michael Gaziano, MD, MPH||Brigham and Women's Hospital|