Trial Information

Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function

Recognition of the biological effects of vitamin D on cardiovascular function has been
growing. The main objective of the parent trial (VITAL) is to evaluate the effects of
vitamin D on cardiac events but is focused on atherothrombotic events and does not
specifically address vitamin D effects on LV mass. In ambulatory individuals, LV mass is a
key cardiac structural feature and increases in LV mass are frequently accompanied by
diastolic dysfunction. This study leverages the existing infrastructure of the parent VITAL
trial to perform cardiac imaging studies on a subset of subjects who will be randomized to
vitamin D3 (n=500) or placebo (n=500). Echocardiography is a noninvasive, widely accessible
tool to evaluate cardiac structure and function. Cardiac echo imaging visits will take place
at baseline (pre-randomization), and then after 2 years, at the Massachusetts General
Hospital (MGH). The acronym VITAL-Echo reflects the link to the parent VITAL trial and an
ancillary investigation of vitamin D versus placebo on LV mass and function as measured by
echocardiography. The effect of fish oil supplementation on these parameters will be
evaluated as a secondary endpoint, thereby taking advantage of the factorial design of the
parent trial.