Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT01728571 |
Other study ID # |
2010-P-000622 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2010 |
Est. completion date |
February 2025 |
Study information
Verified date |
March 2021 |
Source |
Brigham and Women's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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 exacerbations; airflow obstruction
and decline of pulmonary function; and pneumonia. Asthma exacerbations and asthma control are
secondary outcomes. A tertiary goal is to assess whether the effects of the interventions
differ by baseline dietary intake or baseline blood levels of the nutrients.
Depending on the primary outcome, Lung VITAL will be conducted among all participants in
VITAL (NCT 01169259), or in subsets of the VITAL population who were followed by detailed
respiratory questionnaire and/or lung function testing.