Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure

For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart
failure cases occurring during a time period of up to five years starting from randomization
of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the
efficacy of vitamin D as well as omega-3 fatty acids.

Inclusion Criteria:

- Men aged 50 or older or women aged 55 or older

- Be consuming no more than 800 IU of vitamin D from all supplemental sources combined
(individual vitamin D supplements, calcium+vitamin D supplements, medications with
vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to
decrease or forego such use during the trial;

- Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined,
or, if taking, willing to decrease or forego such use during the trial;

- Not be taking fish oil supplements, or, if taking, willing to forego their use during
the trial

Exclusion Criteria:

- prevalent heart failure

- History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient
ischemic attack, angina pectoris, CABG, or PCI

- History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism,
severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such
as active chronic tuberculosis or Wegener's granulomatosis;

- Allergy to fish or soy