Laboratory and observational research studies suggest that
vitamin D and marine
omega-3 fatty acids may reduce risk for
pneumonia, acute exacerbations of
respiratory diseases including
chronic obstructive lung disease (
COPD) or
asthma, and decline of lung function, but prevention trials with adequate dosing, adequate power, and adequate time to follow-up are lacking. The ongoing Lung VITAL study is taking advantage of a large clinical trial-the
VITamin D and OmegA-3 TriaL (VITAL)--to conduct the first major evaluation of the influences of
vitamin D and marine
omega-3 fatty acid supplementation on
pneumonia risk, respiratory exacerbation episodes,
asthma control and lung function in adults. VITAL is a 5-year U.S.-wide randomized, double-blind, placebo-controlled, 2 × 2 factorial trial of supplementation with
vitamin D3 ([
cholecalciferol], 2000 IU/day) and marine omega-3 FA (Omacor®
fish oil,
eicosapentaenoic acid [EPA]+
docosahexaenoic acid [DHA], 1g/day) for primary prevention of CVD and
cancer among men and women, at baseline aged ≥50 and ≥55, respectively, with 5107 African Americans. In a subset of 1973 participants from 11 urban U.S. centers, lung function is measured before and two years after randomization. Yearly follow-up questionnaires assess incident
pneumonia in the entire randomized population, and exacerbations of respiratory disease,
asthma control and
dyspnea in a subpopulation of 4314 randomized participants enriched, as shown in presentation of baseline characteristics, for respiratory disease, respiratory symptoms, and history of cigarette smoking. Self-reported
pneumonia hospitalization will be confirmed by medical record review, and exacerbations will be confirmed by Center for Medicare and Medicaid Services data review.