Cardiovascular Diseases Clinical Trial
Official title:
The Effect of Vitamin D Statues on Endothelial Function
In the United States, cardiovascular disease causes over one-third of all deaths and vitamin
D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status
adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D
deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction.
Moreover, we hypothesize that vitamin D supplementation will restore endothelial function,
thereby reducing cardiovascular disease risk.
This pilot research will be conducted in 64 post-menopausal women participating in an
existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the
others matching placebo) and will explore the effects of vitamin D on endothelial function
and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their
highest risk for development of a subsequent new cardiovascular disease diagnosis. All study
participants will have fasting laboratory and noninvasive vascular ultrasound studies
performed at baseline and four months later. The primary outcome measure of this pilot study
is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.
If our hypotheses are correct, our long-term goals include investigation of the effect of
vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.
n/a
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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