LungVITamin D and OmegA-3 Trial (lungVITAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Diane Gold, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01728571
First received: October 25, 2012
Last updated: April 8, 2014
Last verified: April 2014

October 25, 2012
April 8, 2014
July 2010
October 2017   (final data collection date for primary 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 [ Time Frame: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year ] [ Designated as safety issue: No ]
    Baseline respiratory symptom status and COPD (chronic obstructive pulmonary disease) exacerbations in the past year are measured pre-randomization and annually during follow-up.
  • change in pulmonary function [ Time Frame: pre-randomization and after 2 years follow-up ] [ Designated as safety issue: No ]
    In a sub-group of study participants pulmonary function will be measured pre-randomization and after 2 years of follow-up
  • Change in number of participants with pneumonia in the past year over the course of the study [ Time Frame: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year ] [ Designated as safety issue: No ]
    Pneumonia prevalence overall and in those with COPD and asthma is measured pre-randomization and pneumonia incidence is measured annually during follow-up.
Same as current
Complete list of historical versions of study NCT01728571 on ClinicalTrials.gov Archive Site
  • Change in Number of participants with asthma diagnosis over the course of the study [ Time Frame: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year ] [ Designated as safety issue: No ]
    Participants are asked for "ever asthma" at baseline and "asthma in the past year" annually during follow-up.
  • Change in severity of asthma symptoms during the past week (only for participant who answer "yes" to asthma)) over the course of the study [ Time Frame: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year ] [ Designated as safety issue: No ]
    Asthma symptoms and use of controller and rescue medication are measured pre-randomization and annually during follow-up.
Same as current
Not Provided
Not Provided
 
LungVITamin D and OmegA-3 Trial (lungVITAL)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • COPD
  • Asthma
  • Pulmonary Function
  • Pneumonia
  • Dietary Supplement: Vitamin D
    Other Name: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol
  • Dietary Supplement: fish oil
    Other Name: Omacor, 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
  • Dietary Supplement: Vitamin D placebo
    Other Name: Vitamin D3 placebo
  • Dietary Supplement: Fish oil placebo
    Other Name: Fish oil placebo
  • Active Comparator: Vitamin D + fish oil
    Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
    Interventions:
    • Dietary Supplement: Vitamin D
    • Dietary Supplement: fish oil
  • Active Comparator: Vitamin D + fish oil placebo
    Dietary Supplement: vitamin D3 Dietary Supplement: Fish oil placebo
    Interventions:
    • Dietary Supplement: Vitamin D
    • Dietary Supplement: Fish oil placebo
  • Active Comparator: Vitamin D placebo + fish oil
    Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 placebo
    Interventions:
    • Dietary Supplement: fish oil
    • Dietary Supplement: Vitamin D placebo
  • Placebo Comparator: Vitamin D placebo + fish oil placebo
    Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo
    Interventions:
    • Dietary Supplement: Vitamin D placebo
    • Dietary Supplement: Fish oil placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25875
October 2017
October 2017   (final data collection date for primary outcome measure)
  • 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.
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01728571
2010-P-000622
Yes
Diane Gold, Brigham and Women's Hospital
Brigham and Women's Hospital
Harvard School of Public Health
Principal Investigator: Diane R Gold, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP