LungVITamin D and OmegA-3 Trial (lungVITAL)

Not Applicable

Active, not recruiting

• Conditions: Pneumonia; Pulmonary Function; COPD; Asthma
• Interventions: Dietary Supplement: Vitamin D3; Dietary Supplement: fish oil; Dietary Supplement: Fish oil placebo; Dietary Supplement: Vitamin D3 placebo

• Registration Number: NCT01728571
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Primary Completion: 2018-11-10
• Status Verified: 2024-08
• Study Completion: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25871

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 + fish oil	fish oil	Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
Vitamin D3 + fish oil placebo	Fish oil placebo	Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo
Vitamin D3 + fish oil	Vitamin D3	Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
Vitamin D3 placebo + fish oil placebo	Fish oil placebo	Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo
Vitamin D3 + fish oil placebo	Vitamin D3	Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo
Vitamin D3 placebo + fish oil	fish oil	Drug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo
Vitamin D3 placebo + fish oil	Vitamin D3 placebo	Drug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo
Vitamin D3 placebo + fish oil placebo	Vitamin D3 placebo	Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo

Primary Outcome Measures

Name	Time	Method
COPD exacerbations in the past year over the course of the study	at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year	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.
Airflow obstruction/change in pulmonary function	pre-randomization and after 2 years follow-up	In a sub-group of study participants pulmonary function will be measured pre-randomization and after 2 years of follow-up
Pneumonia in the past year over the course of the study	at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year	Pneumonia in the past year (overall and in those with COPD and asthma) is measured pre-randomization and annually during follow-up.

Secondary Outcome Measures

Name	Time	Method
Asthma exacerbations and asthma control in the past year over the course of the study	at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year	Participants who report an asthma diagnosis are asked questions related to respiratory illness exacerbations and asthma control annually during follow-up.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States