Related trials
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See also:
All cardiovascular prevention clinical trials
All clinical trials of antioxydants
All clinical trials of combination
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Treatments
Studied treatment |
400 IU of vitamin E every other day and
500 mg of vitamin C daily
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Control treatment |
placebo
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Remarks |
factorial design with : beta-caroten, vit E and ascorbic acid, multivitamin |
Patients
Patients |
US male physicians enrolled, aged 50 years or older |
Remarks |
7641 men from the PHS agreed to participate in the PHSII and, beginning in August 1997, were randomized to PHSII study treatments. Treatment assignment to beta carotene or placebo was retained from the PHS (although participants may have stopped taking beta carotene during the 18-month interval between studies), and the men were newly randomized to receive vitamin E, ascorbic acid, multivitamin, or placebo. |
Method and design
Randomized effectives |
2967 / 2989 (studied vs. control) |
Design |
Factorial plan |
Blinding |
double-blind |
Follow-up duration |
8 years |
Primary endpoint |
cardiovascular events |
Remarks / Comments
only a substudy of cognitive function was published
Results
No results available for this trial
- no clinical endpoint reported
Meta-analysis of all similar trials:
antioxydants in cardiovascular prevention for primary prevention
antioxydants in cardiovascular prevention for all type of patients
Reference(s)
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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;10:125-34
Pubmed
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Hubmed
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Grodstein 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;167:2184-90
Pubmed
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Hubmed
| Fulltext
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Sesso 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;300:2123-33
Pubmed
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Hubmed
| Fulltext
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