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LungVITamin D and OmegA-3 Trial

50 Years
Open (Enrolling by invite only)
COPD, Asthma, Pulmonary Function, Pneumonia

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Trial Information

LungVITamin D and OmegA-3 Trial

Chronic obstructive lung disease (COPD) and pneumonia are leading causes of death in United
States and worldwide. COPD, which is also a significant source of disability, is increasing
in prevalence. Approximately 14 million adults have asthma, which leads to approximately 12
million missed work days per year in the United States. In adults, COPD and asthma often
coexist. Treatment options for COPD are limited, and prevalence of vitamin D deficiency is
high. COPD lung disease (COPD, asthma, airflow obstruction), and most COPD additional
co-morbidities responsible for COPD progression (e.g., respiratory infections/pneumonia,
muscle weakness, cardiac failure) may benefit from vitamin D supplementation therapy, but
this requires rigorous testing. Marine omega-3 fatty acids work through different pathways
from vitamin D to affect inflammation. Observational studies and clinical trials suggest
that consumption of fish and/or fish oil may protect against COPD, asthma or pneumonia, but
the data are not consistent. Thus, there is a compelling need for a clinical trial to
evaluate the potential benefits or risks of vitamin D and fish oil supplementation on COPD
and asthma exacerbations, airflow obstruction and decline of lung function, and risk of

The primary outcomes of interest in Lung VITAL are COPD/asthma exacerbations and dyspnea
(shortness of breath); airflow obstruction and decline of pulmonary function; and pneumonia.
Asthma control is a secondary outcome; and new-onset COPD and asthma are tertiary outcomes.

Lung VITAL will be conducted among all 20,000 participants in VITAL (NCT 01169259).
Additionally, the effects of vitamin D and fish oil supplementation on the level of as well
as the rate of decline of lung function will be evaluated in a subset of VITAL participants
during home visits or clinic visits.

Inclusion Criteria

- This study is open to all VITAL participants (NCT 01169259).

- Participants who live in 10 selected metropolitan areas of the U.S. (where we set up
the infrastructure for home visits), are eligible for pulmonary function

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change in number of participants with COPD diagnosis or with treatment of COPD symptoms in the past year over the course of the study

Outcome Description:

Baseline respiratory symptom status and COPD (chronic obstructive pulmonary disease) exacerbations in the past year are measured pre-randomization and annually during follow-up.

Outcome Time Frame:

at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year

Safety Issue:


Principal Investigator

Diane R Gold, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

June 2016

Related Keywords:

  • COPD
  • Asthma
  • Pulmonary Function
  • Pneumonia
  • COPD
  • asthma
  • pulmonary function
  • pneumonia
  • Asthma
  • Pulmonary Disease, Chronic Obstructive
  • Pneumonia



Brigham and Women's Hospital Boston, Massachusetts  02115