VITAL 2018.

Trial name or title	VITamin D and omegA‐3 triaL (VITAL)
Methods	RCT
Participants	Multi‐ethnic population of > 25,000 apparently healthy adults (men 50 years plus, women 55 years plus) without cancer or CVD at baseline
Interventions	Each for mean 5 years: Arm 1: omega‐3 (Omacor fish oil, EPA + DHA 1 g/d: 465 mg EPA; 375 mg DHA) and placebo Arm 2: placebo and vitamin D3 (1/d, 2,000IU) Arm 3: omega‐3 (Omacor fish oil, EPA + DHA 1 g/d: 465 mg EPA; 375 mg DHA) and vitamin D3 (1/d, 2000 IU) Arm 4: placebo and placebo
Outcomes	Primary: reduction in risk for total cancer and CVD events (a composite of MI, stroke, and cardiovascular mortality) Secondary: lowered risk for expanded composite cardiovascular endpoint (MI, stroke, cardiovascular mortality, coronary revascularisation), the individual components of the primary endpoint, site specific cancers, mortality, diabetes, hypertension, cognitive decline, autoimmune conditions, infections, chronic respiratory disease, depression, bone health, fractures, chronic knee pain, body composition, physical disability, falls, plasma biomarker measures
Starting date	Registered on trials registry: 13 January 2010 Study start date: July 2010 Estimated study completion date: December 2017
Contact information	JoAnn Manson or Julie Buring (PIs), Brigham and Women's Hospital, Boston and Harvard School of Public Health, Boston, vitalstudy@rics.bwh.harvard.edu
Notes	NCT01169259 www.vitalstudy.org

ACS: acute coronary syndrome; AD: Alzheimer's disease; AF: atrial fibrillation; BMI: body mass index; BMI: body mass index; CABG: coronary artery bypass graft; CETP: cholesteryl ester transfer protein; CHD: coronary heart disease; CVD: cardiovascular disease; DHA: docosahexaenoic acid; EPA: eicosapentaenoic acid; GAD‐7: generalised anxiety disorder 7; HbA1c: glycated haemoglobin; HDL: high‐density lipoprotein; IFG: impaired fasting glucose; IGT: impaired glucose tolerance; IL: interleukin; LDL: low‐density lipoprotein; MACE: major adverse coronary event; MI: myocardial infarction; MRI: magentic resonance imaging; OCT: optical coherence tomography; OSDI: ocular surface disease index; PCI: percutaneous coronary intervention; PHQ‐9: patient health questionnaire 9; PI: principal investigator; PSA: prostate specific antigen; PSQI: Pittsburgh Sleep Quality Index; PUFA: poly‐unsaturated fatty acids; RCT: randomised controlled trial; RCT: randomised controlled trial; SFA: saturated fatty acids; SVG: saphenous vein graft.