Physicians' Health Study II (PHS II)

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

John Michael Gaziano, MD, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT00270647

First received: December 27, 2005

Last updated: July 17, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 27, 2005

Last Updated Date

July 17, 2012

Start Date ^ICMJE

July 1997

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Prostate cancer [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Total cancer [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Major cardiovascular events [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00270647 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cataract [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Age-related macular degeneration [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Early cognitive decline [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Myocardial infarction [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Stroke [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Colorectal cancer [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Physicians' Health Study II

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Cancer
Prostate Cancer
Colorectal Cancer
Cardiovascular Disease
Eye Disease
Cognitive Decline

Intervention ^ICMJE

Dietary Supplement: Vitamin E
400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)
Dietary Supplement: Vitamin C
500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)
Dietary Supplement: Multivitamin
Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
Dietary Supplement: Beta-carotene
50 mg Lurotin or placebo on alternate days (provided by BASF)

Study Arm (s)

Experimental: Vitamin E
Active or placebo vitamin E

Intervention: Dietary Supplement: Vitamin E
Experimental: Vitamin C
Active or placebo vitamin C

Intervention: Dietary Supplement: Vitamin C
Experimental: Multivitamin
Active or placebo multivitamin

Intervention: Dietary Supplement: Multivitamin
Experimental: Beta-carotene
Active or placebo beta-carotene

Intervention: Dietary Supplement: Beta-carotene

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

14641

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

INCLUSION CRITERIA

DISEASE CHARACTERISTICS:
- Healthy male physicians practicing in the United States
- Prior participation in the Physicians' Health Study I allowed
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
PRIOR CONCURRENT THERAPY:
- No other concurrent vitamin and/or multivitamin supplementation
- No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00270647

Other Study ID Numbers ^ICMJE

CDR0000448630, BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405, R01CA097193

Has Data Monitoring Committee

Yes

Responsible Party

John Michael Gaziano, MD, Brigham and Women's Hospital

Study Sponsor ^ICMJE

Brigham and Women's Hospital

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

J. Michael Gaziano, MD, MPH

Brigham and Women's Hospital

Information Provided By

Brigham and Women's Hospital

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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