COPDlungVITALNCT01728571

LungVITamin D and OmegA-3 Trial (lungVITAL)

A study testing Vitamin D3 and fish oil in people with COPD and Asthma, run by Brigham and Women's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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… Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: COPD, Asthma, Pulmonary Function
What is being tested?: Vitamin D3 and fish oil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25,871 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Nov 2027
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: LungVITamin D and OmegA-3 Trial

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.

Read the 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.

Conditions: COPD, Asthma, Pulmonary Function, Pneumonia
Being tested: Vitamin D3, fish oil, Vitamin D3 placebo, Fish oil placebo
Keywords: COPD, asthma, pulmonary function, pneumonia
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Asthma, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3Dietary supplement
Also called Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol
fish oilDietary supplement
Also called 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]).
Vitamin D3 placeboDietary supplement
Fish oil placeboDietary supplement

Study groups in NCT01728571
Study group	Role	What they receive
Vitamin D3 + fish oil	Active comparator	Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil) Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: fish oil
Vitamin D3 + fish oil placebo	Active comparator	Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Fish oil placebo
Vitamin D3 placebo + fish oil	Active comparator	Drug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo Receives: Dietary Supplement: fish oil; Dietary Supplement: Vitamin D3 placebo
Vitamin D3 placebo + fish oil placebo	Placebo comparator	Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo Receives: Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

COPD Exacerbations Expressed as Cumulative Rate/Year Over 5 Years
The primary questionnaire-based outcome was COPD respiratory exacerbations, defined for those with COPD as the number of episodes in the past 12 months of a flare-up of chest trouble treated with additional antibiotic or steroid medication at home, or resulting in hospitalization
Measured: 5 years
Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1))
In a sub-group of study participants change in pulmonary function (FEV1) will be measured between pre-randomization and 2 years of follow-up
Measured: pre-randomization and after 2 years follow-up
Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC))
In a sub-group of study participants change in pulmonary function (FEV1/FVC) will be measured between pre-randomization and 2 years of follow-up
Measured: 2 years
Pneumonia
The rate of pneumonia incidence per year
Measured: 5 years

Secondary outcomes (1)

Asthma Exacerbations Expressed as Cumulative Rate/Year Over 5 Years
The secondary questionnaire-based outcome was asthma respiratory exacerbations, defined for those with asthma (by questionnaire report) as the number of episodes in the past 12 months of a flare-up of chest trouble treated with additional antibiotic or steroid medication at home, or resulting in hospitalization
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Nov 2027

First posted20 Nov 2012 (estimated)
Study startJul 2010
Primary completion11 Oct 2018
Study completionNov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 25,871 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01728571
Sponsor's protocol ID: 2010-P-000622
Other IDs: R01HL101932, R01AT011729, U01CA138962, R01CA138962
Acronym: lungVITAL
Status last verified: Jul 2026
First submitted: 25 Oct 2012
Last updated: 7 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gold DR, Carey VJ, Hersh CP, Wan E, Camargo CA Jr, Lee IM, Cook NR, Nassikas N, Buring JE, Manson JE, Luttmann-Gibson H. Vitamin D Supplementation, Chronic Obstructive Lung Disease and Asthma Exacerbations, and Lung Function Decline. J Nutr. 2025 May;155(5):1417-1428. doi: 10.1016/j.tjnut.2025.02.003. Epub 2025 Feb 6.
PubMed 39922497
Gold DR, Litonjua AA, Carey VJ, Manson JE, Buring JE, Lee IM, Gordon D, Walter J, Friedenberg G, Hankinson JL, Copeland T, Luttmann-Gibson H. Lung VITAL: Rationale, design, and baseline characteristics of an ancillary study evaluating the effects of vitamin D and/or marine omega-3 fatty acid supplements on acute exacerbations of chronic respiratory disease, asthma control, pneumonia and lung function in adults. Contemp Clin Trials. 2016 Mar;47:185-95. doi: 10.1016/j.cct.2016.01.003. Epub 2016 Jan 16.
PubMed 26784651

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LungVITamin D and OmegA-3 Trial
ClinicalTrials.gov ID: NCT01728571
Acronym / sponsor ID: lungVITAL / 2010-P-000622
Conditions: COPD, Asthma, Pulmonary Function, Pneumonia
Keywords: COPD, asthma, pulmonary function, pneumonia
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 25,871 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Harvard School of Public Health (HSPH), National Heart, Lung, and Blood Institute (NHLBI), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI)
Study start: Jul 2010 (actual)
Primary completion: 11 Oct 2018 (actual)
Study completion: Nov 2027 (estimated)
First posted: 20 Nov 2012 (estimated)
Results: Posted 7 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Vitamin D3 + fish oil	Active comparator	Dietary Supplement: Vitamin D3, Dietary Supplement: fish oilDietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
Vitamin D3 + fish oil placebo	Active comparator	Dietary Supplement: Vitamin D3, Dietary Supplement: Fish oil placeboDietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo
Vitamin D3 placebo + fish oil	Active comparator	Dietary Supplement: fish oil, Dietary Supplement: Vitamin D3 placeboDrug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo
Vitamin D3 placebo + fish oil placebo	Placebo comparator	Dietary Supplement: Vitamin D3 placebo, Dietary Supplement: Fish oil placeboDietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin D3Also: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol	Dietary supplement	Vitamin D3 + fish oil, Vitamin D3 + fish oil placebo
fish oilAlso: 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 + fish oil, Vitamin D3 placebo + fish oil
Vitamin D3 placebo	Dietary supplement	Vitamin D3 placebo + fish oil, Vitamin D3 placebo + fish oil placebo
Fish oil placebo	Dietary supplement	Vitamin D3 + fish oil placebo, Vitamin D3 placebo + fish oil placebo

Primary outcome

COPD Exacerbations Expressed as Cumulative Rate/Year Over 5 Years
Time frame: 5 years
The primary questionnaire-based outcome was COPD respiratory exacerbations, defined for those with COPD as the number of episodes in the past 12 months of a flare-up of chest trouble treated with additional antibiotic or steroid medication at home, or resulting in hospitalization
Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1))
Time frame: pre-randomization and after 2 years follow-up
In a sub-group of study participants change in pulmonary function (FEV1) will be measured between pre-randomization and 2 years of follow-up
Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC))
Time frame: 2 years
In a sub-group of study participants change in pulmonary function (FEV1/FVC) will be measured between pre-randomization and 2 years of follow-up
Pneumonia
Time frame: 5 years
The rate of pneumonia incidence per year

1 secondary outcome

Asthma Exacerbations Expressed as Cumulative Rate/Year Over 5 Years
Time frame: 5 years

Results and safety

Results posted to the registry on 7 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin D3 + Fish Oil	6,463	6,463
Vitamin D3 + Fish Oil Placebo	6,464	6,464
Vitamin D3 Placebo + Fish Oil	6,470	6,470
Vitamin D3 Placebo + Fish Oil Placebo	6,474	6,474

Primary outcome: COPD Exacerbations Expressed as Cumulative Rate/Year Over 5 Years

Time frame: 5 years. Mean (Standard Deviation). Unit: exacerbations per year

Measure	Active Vitamin D n = 995	Vitamin D Placebo n = 982	Active Omega-3 Fatty Acids n = 950	Omega-3 Fatty Acids Placebo n = 2027
Value	0.27 (0.49)	0.25 (0.48)	0.27 (0.52)	0.25 (0.44)

Population analysed: Population with COPD. COPD was defined by questionnaire as doctor's diagnosis of COPD or emphysema, or chronic bronchitis by ATS-DLD criteria. Health care utilization (self-reported), a secondary outcome, was assessed as counts in the past year of emergency room visits or hospitalization for lung problems for those with COPD.

Primary outcome: Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1))

Time frame: pre-randomization and after 2 years follow-up. Mean (Standard Deviation). Unit: milliliters

Measure	Active Vitamin D n = 799	Vitamin D Placebo n = 826	Active Omega-3 Fatty Acids n = 821	Omega-3 Fatty Acids Placebo n = 804
Value	-32.3 (89.3)	-35.8 (89.5)	-34.1 (89.8)	-34.1 (89.0)

Population analysed: On the basis of residence in one of 12 continental U.S. urban locations where we created spirometry training sites, regardless of prior respiratory disease history, VITAL participants were invited for home- or clinic-based Lung VITAL pulmonary function testing by trained technicians.

Primary outcome: Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC))

Time frame: 2 years. Mean (Standard Deviation). Unit: FEV1/FVC ratio

Measure	Active Vitamin D n = 799	Vitamin D Placebo n = 826	Active Omega-3 Fatty Acids n = 821	Omega-3 Fatty Acids Placebo n = 804
Value	-0.2 (1.8)	-0.2 (1.9)	-0.1 (1.9)	-0.3 (1.8)

Primary outcome: Pneumonia

Time frame: 5 years. Mean (Standard Deviation). Unit: pneumonia events per year

Measure	Active Vitamin D n = 12595	Vitamin D Placebo n = 12581	Active Omega-3 Fatty Acids n = 12575	Omega-3 Fatty Acids Placebo n = 12601
Value	0.020 (0.094)	0.019 (0.090)	0.020 (0.092)	0.020 (0.092)

Population analysed: Entire parent grant (VITAL) population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Vitamin D	1,673 of 12,927 (12.9%)	10,086 of 12,927 (78%)	485 of 12,927
Vitamin D Placebo	1,659 of 12,944 (12.8%)	10,098 of 12,944 (78%)	493 of 12,944
Active Omega-3 Fatty Acids	1,613 of 12,933 (12.5%)	10,094 of 12,933 (78%)	493 of 12,933
Omega-3 Fatty Acids Placebo	1,619 of 12,938 (12.5%)	10,090 of 12,938 (78%)	485 of 12,938
Active Vitamin D/Active Omega-3 Fatty Acids	791 of 6,463 (12.2%)	5,101 of 6,463 (78.9%)	241 of 6,463
Active Vitamin D/Placebo Omega-3 Fatty Acids	782 of 6,464 (12.1%)	5,027 of 6,464 (77.8%)	244 of 6,464
Placebo Vitamin D/Active Omega-3 Fatty Acids	822 of 6,470 (12.7%)	5,037 of 6,470 (77.9%)	252 of 6,470
Placebo Vitamin D/Placebo Omega-3 Fatty Acids	837 of 6,474 (12.9%)	5,101 of 6,474 (78.8%)	241 of 6,474

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39922497Gold DR, Carey VJ, Hersh CP, Wan E, Camargo CA Jr, Lee IM, Cook NR, Nassikas N, Buring JE, Manson JE, Luttmann-Gibson H. Vitamin D Supplementation, Chronic Obstructive Lung Disease and Asthma Exacerbations, and Lung Function Decline. J Nutr. 2025 May;155(5):1417-1428. doi: 10.1016/j.tjnut.2025.02.003. Epub 2025 Feb 6.
Derived from this study: PubMed 26784651Gold DR, Litonjua AA, Carey VJ, Manson JE, Buring JE, Lee IM, Gordon D, Walter J, Friedenberg G, Hankinson JL, Copeland T, Luttmann-Gibson H. Lung VITAL: Rationale, design, and baseline characteristics of an ancillary study evaluating the effects of vitamin D and/or marine omega-3 fatty acid supplements on acute exacerbations of chronic respiratory disease, asthma control, pneumonia and lung function in adults. Contemp Clin Trials. 2016 Mar;47:185-95. doi: 10.1016/j.cct.2016.01.003. Epub 2016 Jan 16.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Diane R Gold, MD, MPH principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 and fish oil in people with COPD and Asthma, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COPD Exacerbations Expressed as Cumulative Rate/Year Over 5 Years (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728571, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.