title: Lung VITAL: Rationale, design, and baseline characteristics of an ancillary study evaluating the effects of vitamin D and/or marine omega-3 fatty acid supplements on acute exacerbations of chronic respiratory disease, asthma control, pneumonia and lung function in adults.
abstract: 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.
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: diane.gold@channing.harvard.edu.
authors.forename: Diane R
authors.initials: DR
authors.lastname: Gold
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: reaal@channing.harvard.edu.
authors.forename: Augusto A
authors.initials: AA
authors.lastname: Litonjua
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: vincent.carey@channing.harvard.edu.
authors.forename: Vincent J
authors.initials: VJ
authors.lastname: Carey
authors.affiliation: Harvard Medical School, Boston, MA, United States; Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Department of Epidemiology, Harvard T.H.Chan School of Public Health, Boston, MA, United States. Electronic address: jmanson@rics.bwh.harvard.edu.
authors.forename: JoAnn E
authors.initials: JE
authors.lastname: Manson
authors.affiliation: Harvard Medical School, Boston, MA, United States; Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Department of Epidemiology, Harvard T.H.Chan School of Public Health, Boston, MA, United States. Electronic address: jburing@rics.bwh.harvard.edu.
authors.forename: Julie E
authors.initials: JE
authors.lastname: Buring
authors.affiliation: Harvard Medical School, Boston, MA, United States; Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Department of Epidemiology, Harvard T.H.Chan School of Public Health, Boston, MA, United States. Electronic address: ilee@rics.bwh.harvard.edu.
authors.forename: I-Min
authors.initials: IM
authors.lastname: Lee
authors.affiliation: Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States. Electronic address: dgordon@rics.bwh.harvard.edu.
authors.forename: David
authors.initials: D
authors.lastname: Gordon
authors.affiliation: Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States. Electronic address: JWALTER@research.bwh.harvard.edu.
authors.forename: Joseph
authors.initials: J
authors.lastname: Walter
authors.affiliation: Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States. Electronic address: gfriedenberg@rics.bwh.harvard.edu.
authors.forename: Georgina
authors.initials: G
authors.lastname: Friedenberg
authors.affiliation: Hankinson Consulting, Inc., Athens, GA, United States. Electronic address: john@occspiro.com.
authors.forename: John L
authors.initials: JL
authors.lastname: Hankinson
authors.affiliation: Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States. Electronic address: PCOPELAND2@partners.org.
authors.forename: Trisha
authors.initials: T
authors.lastname: Copeland
authors.affiliation: Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, United States. Electronic address: hgibson@hsph.harvard.edu.
authors.forename: Heike
authors.initials: H
authors.lastname: Luttmann-Gibson
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000188:drug therapy*; D002762:Cholecalciferol / Q000627:therapeutic use*; D002985:Clinical Protocols; D019587:Dietary Supplements; D018450:Disease Progression; D004281:Docosahexaenoic Acids / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008168:Lung / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000517:prevention & control*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012107:Research Design; D016896:Treatment Outcome; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D014815:Vitamins; D002762:Cholecalciferol; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; C405603:Omacor
keywords: COPD; Lung function; Omega-3 fatty acids; Randomized clinical trial; Respiratory symptoms; Vitamin D