physicians' health study ii

Conditions: Cancer; Prostate Cancer; Colorectal Cancer; Cardiovascular Disease; Eye Disease; Cognitive Decline

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.

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 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)

Keywords: cancer prostate cancer colorectal cancer cardiovascular disease eye disease cognitive decline