LungVITamin D and OmegA-3 Trial (lungVITAL)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Asthma, Asthma, Chronic Obstructive Pulmonary Disease, Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 1/18/2019 |
| Start Date: | July 2010 |
| End Date: | November 2020 |
LungVITamin D and OmegA-3 Trial
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial
in 25,875 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 improves respiratory symptoms or reduces the risk of lung infections or
reduces the decline of pulmonary function.
in 25,875 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 improves respiratory symptoms or reduces the risk of lung infections or
reduces the decline of pulmonary function.
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 pneumonia.
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.
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 pneumonia.
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.
- 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 measurements.
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