Physicians' Health Study II
Nyckelord
Abstrakt
Beskrivning
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.
Datum
| Senast verifierad: | 01/31/2018 |
| Först skickat: | 12/26/2005 |
| Beräknad anmälan inlämnad: | 12/26/2005 |
| Först publicerad: | 12/27/2005 |
| Senaste uppdatering skickad: | 02/25/2018 |
| Senaste uppdatering publicerad: | 02/27/2018 |
| Faktiskt startdatum för studien: | 06/30/1997 |
| Uppskattat primärt slutdatum: | 05/31/2011 |
| Beräknat slutfört datum: | 05/31/2011 |
Tillstånd eller sjukdom
Intervention / behandling
Dietary Supplement: Vitamin E
Dietary Supplement: Vitamin C
Dietary Supplement: Multivitamin
Dietary Supplement: Beta-carotene
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| 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) |
| Experimental: Multivitamin Active or placebo multivitamin | Dietary Supplement: Multivitamin Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle)) |
| Experimental: Beta-carotene Active or placebo beta-carotene | Dietary Supplement: Beta-carotene 50 mg Lurotin or placebo on alternate days (provided by BASF) |
Urvalskriterier
| Åldrar berättigade till studier | 50 Years Till 50 Years |
| Kön som är berättigade till studier | Male |
| Accepterar friska volontärer | Ja |
| Kriterier | 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) |
Resultat
Primära resultatåtgärder
1. Prostate cancer [Ongoing]
2. Total cancer [Ongoing]
3. Major cardiovascular events [Ongoing]
Sekundära resultatåtgärder
1. Cataract [Ongoing]
2. Age-related macular degeneration [Ongoing]
3. Early cognitive decline [Ongoing]
4. Myocardial infarction [Ongoing]
5. Stroke [Ongoing]
6. Colorectal cancer [Ongoing]
