WHS vitamin E, 2005 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of vitamin E versus placebo in apparently healthy US women aged at least 45 years

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NCT00000479    JAMA 2005;294:56-65  



Studied treatment vitamin E 600 IU every other day (รก-tocopherol)
Control treatment placebo
Women (%) 100%
age (yr) 54.6 y

factorial design vitamin E or placebo and aspirin or placebo



Patients apparently healthy US women aged at least 45 years
Group sizes19937 / 19939
Inclusion criteriaage 45 years or older; no previous history of coronary heart disease, cerebrovascular disease, cancer (except nonmelanoma skin cancer), or other major chronic illnesses; no history of adverse effects from aspirin; no use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) more than once a week, or willingness to forgo their use; no use of anticoagulants or corticosteroids; and no use of individual supplements of vitamin A, E, or beta carotene more than once a week
Body mass index 26.04



Blindness double-blind Inclusion period sept 1992 - may 1995
Follow-up duration 10.1 y Centers
Lost to FU 2.8% (morbidity) geographical localisation US
Primary endpoint major cardiovascular event Design Factorial plan
PeriodeInclusionsept 1992 - may 1995
HypotheseSuperiority

two primary endpoint specified without method for dealing with multiplicity



EndpointX1N1X0N0TE95% CI coronary events - 19937 - 19939 no data coronary death - 19937 - 19939 no data non fatal stroke - 19937 - 19939 no data Hemorrhagic Stroke 44 19937 48 19939 0,92[0,61; 1,38] all-cause cerebrovascular accident 241 19937 246 19939 0,98[0,82; 1,17] Cardiovascular Event - 19937 - 19939 no data all-cause mortality - 19937 - 19939 no data non fatla MI - 19937 - 19939 no data Ischemic Stroke 194 19937 197 19939 0,98[0,81; 1,20] cardiovascular death - 19937 - 19939 no data0,22,01,0

Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial. JAMA 2005;294:56-65     [PMID: 15998891]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT00000479



Registering number NCT00000479 (see trial on clinicaltrials.gov)
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All trials of vitamin E

Appears in following systematic reviews: