The Women's Health Initiative: Clinical Trials (WHI-CT)
Objectives:
To assess the safety and efficacy of three interventions on cardiovascular disease (CVD),
cancer, and osteoporosis in postmenopausal women.
Background:
The clinical trial component of the WHI included three, overlapping randomized comparisons: hormone therapy,
dietary modification, and calcium/vitamin D supplementation. The hormone therapy trial randomized
womento one of two double-blinded trials: estrogen plus progestin or estrogen alone. The dietary modification
trial evaluated the effect of a low-fat, high fruit, vegetable, and grain diet on preventing CVD and
cancer. The calcium/vitamin D randomized women to either supplements or placebo. Women could have been randomized
into one, two or all three trials.
Subjects:
A total of 68,132 women, aged 50-79 years were randomized into the three trials. The hormone therapy trial enrolled
16,608 women, 48,835 were randomized into the diet modification trial, and 36,282 were randomized into the
calcium/vitamin D trial. Recruitment was carried out in 40 US clinical centers in 1993-1998.
Conclusions:
Overall health risks exceeded benefits from use of
combined estrogen plus progestin after an average 5.2 year follow-up among
healthy postmenopausal US women (JAMA 2002;288:321-333). Over approximately 8 years of follow-up, a low-fat dietary pattern
did not reduce the risk of colorectal cancer (JAMA 2006;295:643-654). Calcium with vitamin D supplementation resulted in a
small but significant improvement in hip bone density; however, no significant difference was observed in hip
fractures (N Engl J Med 2006;354:669-683).
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Study Website |
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Study Documentation |
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Data Distribution Agreement |
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