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Physicians' Health Study II

Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00270647
Acronym
PHS II
Enrollment
14641
Registered
2005-12-28
Start date
1997-07-31
Completion date
2011-06-30
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cardiovascular Disease, Cognitive Decline, Colorectal Cancer, Eye Disease, Prostate Cancer

Keywords

cancer, prostate cancer, colorectal cancer, cardiovascular disease, eye disease, cognitive decline

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.

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.

Interventions

DIETARY_SUPPLEMENTVitamin E

400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)

DIETARY_SUPPLEMENTVitamin C

500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)

DIETARY_SUPPLEMENTMultivitamin

Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))

DIETARY_SUPPLEMENTBeta-carotene

50 mg Lurotin or placebo on alternate days (provided by BASF)

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Prostate cancerOngoing
Total cancerOngoing
Major cardiovascular eventsOngoing

Secondary

MeasureTime frame
Myocardial infarctionOngoing
CataractOngoing
Colorectal cancerOngoing
StrokeOngoing
Age-related macular degenerationOngoing
Early cognitive declineOngoing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026