LungVITamin D and OmegA-3 Trial (lungVITAL)

Asthma Clinical Trial

— lungVITAL  

Official title:

LungVITamin D and OmegA-3 Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01728571
• Other study ID #: 2010-P-000622
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25871
• Est. completion date: February 2025
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

• This study is open to all VITAL participants (NCT 01169259). Population includes men 50 years of age or older and women 55 years of age or older in the United States

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

Related Conditions & MeSH terms

• Asthma
• COPD
• Pneumonia
• Pulmonary Function

Intervention

Dietary Supplement:
• Vitamin D3

• fish oil

• Vitamin D3 placebo

• Fish oil placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Harvard School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD exacerbations in the past year over the course of the study	Baseline respiratory symptom status, respiratory disease diagnoses, and COPD (chronic obstructive pulmonary disease) exacerbations in the past year are measured pre-randomization and annually during follow-up.	at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year
Primary	Airflow obstruction/change in pulmonary function	In a sub-group of study participants pulmonary function will be measured pre-randomization and after 2 years of follow-up	pre-randomization and after 2 years follow-up
Primary	Pneumonia in the past year over the course of the study	Pneumonia in the past year (overall and in those with COPD and asthma) is measured pre-randomization and annually during follow-up.	at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year
Secondary	Asthma exacerbations and asthma control in the past year over the course of the study	Participants who report an asthma diagnosis are asked questions related to respiratory illness exacerbations and asthma control annually during follow-up.	at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year