Manson 2009.

Trial name or title	Vitamin D and omega‐3 trial (VITAL)
Methods	Randomised, double‐blind, placebo‐controlled trial using 2 × 2 factorial design
Participants	Country: United States Estimated number of participants: 20,000 Inclusion criteria: men aged 50 or older or women aged 55 or older who have at least a high school education Exclusion criteria: history of cancer (except non‐melanoma skin cancer), heart attack, stroke, transient ischaemic attack, angina pectoris, coronary artery bypass graft or percutaneous coronary intervention; history of renal failure or dialysis, hypercalcaemia, hypoparathyroidism 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; other serious illness that would preclude participation; 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; 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; taking fish oil supplements, or, if taking, willing to forego their use during the trial
Interventions	Intervention group 1: vitamin D3 and omega‐3; Intervention group 2: vitamin D3 and omega‐3 placebo; Intervention group 3: vitamin D placebo and omega‐3; or   Intervention group 4 (control group): vitamin D placebo and omega‐3 placebo orally, daily for a two‐year period
Outcomes	Cancer and cardiovascular disease
Starting date	July 2010
Contact information	Project manager; 1‐800‐388‐3963; vitalstudy@rics.bwh.harvard.edu www.vitalstudy.org
Notes