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Trial record 7 of 13 for:    asthma | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | "vitamin d"

LungVITamin D and OmegA-3 Trial (lungVITAL) (lungVITAL)

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ClinicalTrials.gov Identifier: NCT01728571
Recruitment Status : Active, not recruiting
First Posted : November 20, 2012
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Diane Gold, 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.


Condition or disease Intervention/treatment Phase
COPD Asthma Pulmonary Function Pneumonia Dietary Supplement: Vitamin D3 Dietary Supplement: fish oil Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25871 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: LungVITamin D and OmegA-3 Trial
Study Start Date : July 2010
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vitamin D3 + fish oil
Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3
Other Name: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol

Dietary Supplement: fish oil
Other Name: Omacor; 1 g per day as a fish oil capsule, containing 840 milligrams of marine omega-3 fatty acids (460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]).

Active Comparator: Vitamin D3 + fish oil placebo
Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo
Dietary Supplement: Vitamin D3
Other Name: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol

Dietary Supplement: Fish oil placebo
Active Comparator: Vitamin D3 placebo + fish oil
Drug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo
Dietary Supplement: fish oil
Other Name: Omacor; 1 g per day as a fish oil capsule, containing 840 milligrams of marine omega-3 fatty acids (460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]).

Dietary Supplement: Vitamin D3 placebo
Placebo Comparator: Vitamin D3 placebo + fish oil placebo
Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo
Dietary Supplement: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo



Primary Outcome Measures :
  1. COPD exacerbations 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 ]
    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.

  2. Airflow obstruction/change in pulmonary function [ Time Frame: 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

  3. 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 ]
    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 :
  1. Asthma exacerbations and asthma control 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 ]
    Participants who report an asthma diagnosis are asked questions related to respiratory illness exacerbations and asthma control annually during follow-up.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728571


Locations
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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
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Principal Investigator: Diane R Gold, MD, MPH Brigham and Women's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Diane Gold, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01728571    
Other Study ID Numbers: 2010-P-000622
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Keywords provided by Diane Gold, Brigham and Women's Hospital:
COPD
asthma
pulmonary function
pneumonia
Additional relevant MeSH terms:
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Vitamin D
Pneumonia
Respiratory Tract Diseases
Lung Diseases
Respiratory Tract Infections
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents