Physicians' Health Study II
PHS II
5 other identifiers
interventional
14,641
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Jul 1997
Longer than P75 for not_applicable cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1997
CompletedFirst Submitted
Initial submission to the registry
December 27, 2005
CompletedFirst Posted
Study publicly available on registry
December 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFebruary 28, 2018
February 1, 2018
13.9 years
December 27, 2005
February 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Prostate cancer
Ongoing
Total cancer
Ongoing
Major cardiovascular events
Ongoing
Secondary Outcomes (6)
Cataract
Ongoing
Age-related macular degeneration
Ongoing
Early cognitive decline
Ongoing
Myocardial infarction
Ongoing
Stroke
Ongoing
- +1 more secondary outcomes
Study Arms (4)
Vitamin E
EXPERIMENTALActive or placebo vitamin E
Vitamin C
EXPERIMENTALActive or placebo vitamin C
Multivitamin
EXPERIMENTALActive or placebo multivitamin
Beta-carotene
EXPERIMENTALActive or placebo beta-carotene
Interventions
400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)
500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)
Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
50 mg Lurotin or placebo on alternate days (provided by BASF)
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- National Cancer Institute (NCI)collaborator
Related Publications (13)
Christen WG, Gaziano JM, Hennekens CH. Design of Physicians' Health Study II--a randomized trial of beta-carotene, vitamins E and C, and multivitamins, in prevention of cancer, cardiovascular disease, and eye disease, and review of results of completed trials. Ann Epidemiol. 2000 Feb;10(2):125-34. doi: 10.1016/s1047-2797(99)00042-3.
PMID: 10691066BACKGROUNDGaziano JM, Glynn RJ, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Sesso HD, Buring JE. Vitamins E and C in the prevention of prostate and total cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2009 Jan 7;301(1):52-62. doi: 10.1001/jama.2008.862. Epub 2008 Dec 9.
PMID: 19066368RESULTSesso HD, Buring JE, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Glynn RJ, Gaziano JM. Vitamins E and C in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2008 Nov 12;300(18):2123-33. doi: 10.1001/jama.2008.600. Epub 2008 Nov 9.
PMID: 18997197RESULTChristen WG, Glynn RJ, Sesso HD, Kurth T, Macfadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Vitamins E and C and medical record-confirmed age-related macular degeneration in a randomized trial of male physicians. Ophthalmology. 2012 Aug;119(8):1642-9. doi: 10.1016/j.ophtha.2012.01.053. Epub 2012 Apr 13.
PMID: 22503302RESULTChristen WG, Glynn RJ, Sesso HD, Kurth T, MacFadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Age-related cataract in a randomized trial of vitamins E and C in men. Arch Ophthalmol. 2010 Nov;128(11):1397-405. doi: 10.1001/archophthalmol.2010.266.
PMID: 21060040RESULTGrodstein F, Kang JH, Glynn RJ, Cook NR, Gaziano JM. A randomized trial of beta carotene supplementation and cognitive function in men: the Physicians' Health Study II. Arch Intern Med. 2007 Nov 12;167(20):2184-90. doi: 10.1001/archinte.167.20.2184.
PMID: 17998490RESULTJuraschek SP, Gaziano JM, Glynn RJ, Gomelskaya N, Bubes VY, Buring JE, Shmerling RH, Sesso HD. Effects of vitamin C supplementation on gout risk: results from the Physicians' Health Study II trial. Am J Clin Nutr. 2022 Sep 2;116(3):812-819. doi: 10.1093/ajcn/nqac140.
PMID: 35575611DERIVEDRautiainen S, Gaziano JM, Christen WG, Bubes V, Kotler G, Glynn RJ, Manson JE, Buring JE, Sesso HD. Effect of Baseline Nutritional Status on Long-term Multivitamin Use and Cardiovascular Disease Risk: A Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial. JAMA Cardiol. 2017 Jun 1;2(6):617-625. doi: 10.1001/jamacardio.2017.0176.
PMID: 28384735DERIVEDWang L, Sesso HD, Glynn RJ, Christen WG, Bubes V, Manson JE, Buring JE, Gaziano JM. Vitamin E and C supplementation and risk of cancer in men: posttrial follow-up in the Physicians' Health Study II randomized trial. Am J Clin Nutr. 2014 Sep;100(3):915-23. doi: 10.3945/ajcn.114.085480. Epub 2014 Jul 9.
PMID: 25008853DERIVEDGrodstein F, O'Brien J, Kang JH, Dushkes R, Cook NR, Okereke O, Manson JE, Glynn RJ, Buring JE, Gaziano M, Sesso HD. Long-term multivitamin supplementation and cognitive function in men: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):806-14. doi: 10.7326/0003-4819-159-12-201312170-00006.
PMID: 24490265DERIVEDChristen WG, Glynn RJ, Manson JE, MacFadyen J, Bubes V, Schvartz M, Buring JE, Sesso HD, Gaziano JM. Effects of multivitamin supplement on cataract and age-related macular degeneration in a randomized trial of male physicians. Ophthalmology. 2014 Feb;121(2):525-34. doi: 10.1016/j.ophtha.2013.09.038. Epub 2013 Nov 20.
PMID: 24268861DERIVEDGaziano JM, Sesso HD, Christen WG, Bubes V, Smith JP, MacFadyen J, Schvartz M, Manson JE, Glynn RJ, Buring JE. Multivitamins in the prevention of cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2012 Nov 14;308(18):1871-80. doi: 10.1001/jama.2012.14641.
PMID: 23162860DERIVEDSesso HD, Christen WG, Bubes V, Smith JP, MacFadyen J, Schvartz M, Manson JE, Glynn RJ, Buring JE, Gaziano JM. Multivitamins in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2012 Nov 7;308(17):1751-60. doi: 10.1001/jama.2012.14805.
PMID: 23117775DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Michael Gaziano, MD, MPH
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician, Brigham and Women's Hospital; Professor of Medicine, Harvard Medical School
Study Record Dates
First Submitted
December 27, 2005
First Posted
December 28, 2005
Study Start
July 1, 1997
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
February 28, 2018
Record last verified: 2018-02