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NCT01728571 · ClinicalTrials.gov record · last posted 2026-08-07

LungVITamin D and OmegA-3 Trial (lungVITAL)

Study acronym: lungVITAL
StatusActive, Not Recruiting
PhaseNot applicable
Started2010-07
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.

Protocol amendment history 3 changes detected by DataLookout

2026-08-08
Primary endpoint(s) modified
WasAirflow obstruction/change in pulmonary function, COPD exacerbations in the past year over the course of the study, Pneumonia in the past year over the course of the study
NowCOPD Exacerbations Expressed as Cumulative Rate/Year Over 5 Years, Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1)), Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC)), Pneumonia
2026-08-08
Primary completion moved earlier: 2018-11-10 → 2018-10-11
2026-08-08
Completion pushed: 2025-02 → 2027-11
Trial Details
NCT Number NCT01728571
Lead Sponsor Brigham and Women's Hospital
Collaborators: Harvard School of Public Health (HSPH), National Heart, Lung, and Blood Institute (NHLBI), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI)
Conditions COPD, Asthma, Pulmonary Function, Pneumonia
Enrollment 25,871 participants
Start Date 2010-07
Primary Completion 2018-10-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-07