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
  Purpose

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.


Condition Intervention
COPD
Asthma
Pulmonary Function
Pneumonia
Dietary Supplement: Vitamin D
Dietary Supplement: fish oil
Dietary Supplement: Vitamin D placebo
Dietary Supplement: Fish oil placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: LungVITamin D and OmegA-3 Trial

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 25875
Study Start Date: July 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D + fish oil
Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
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]).
Active Comparator: Vitamin D + fish oil placebo
Dietary Supplement: vitamin D3 Dietary Supplement: Fish oil placebo
Dietary Supplement: Vitamin D
Other Name: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol
Dietary Supplement: Fish oil placebo
Other Name: Fish oil placebo
Active Comparator: Vitamin D placebo + fish oil
Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 placebo
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
Placebo Comparator: Vitamin D placebo + fish oil placebo
Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo
Dietary Supplement: Vitamin D placebo
Other Name: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo
Other Name: Fish oil placebo

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/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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728571

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard School of Public Health
Investigators
Principal Investigator: Diane R Gold, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Diane Gold, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01728571     History of Changes
Other Study ID Numbers: 2010-P-000622
Study First Received: October 25, 2012
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
COPD
asthma
pulmonary function
pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 22, 2014