LungVITamin D and OmegA-3 Trial (lungVITAL)

NCT01728571 | Active Not Recruiting Results DMC

• 5 other identifiers: 2010-P-000622R01HL101932R01AT011729U01CA138962R01CA138962
• Study Type: interventional
• Target: 25,871
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Asthma; Pulmonary Function; Pneumonia

Keywords

COPD; asthma; pulmonary function; pneumonia

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  2 years

• Pneumonia

  The rate of pneumonia incidence per year

  5 years

Secondary Outcomes (1)

• Asthma Exacerbations Expressed as Cumulative Rate/Year Over 5 Years

  5 years

Study Arms (4)

Vitamin D3 + fish oil

ACTIVE COMPARATOR

Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)

Dietary Supplement: Vitamin D3; Dietary Supplement: fish oil

Vitamin D3 + fish oil placebo

ACTIVE COMPARATOR

Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo

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

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

Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Also known as: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol

Vitamin D3 + fish oil; Vitamin D3 + fish oil placebo

fish oil DIETARY_SUPPLEMENT

Also known as: 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 + 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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard School of Public Health (HSPH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Cancer Institute (NCI): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 39922497 DERIVED

• 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.

  PMID: 26784651 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Pneumonia

Interventions

Cholecalciferol; Fish Oils; Omacor; Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Oils; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids

Results Point of Contact

• Title: Diane R Gold MD
• Organization: Brigham and Women's Hospital

diane.gold@channing.harvard.edu

6175252738

Study Officials

• Diane R Gold, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: November 20, 2012
• Study Start: July 1, 2010
• Primary Completion: October 11, 2018
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 7, 2026
• Results First Posted: August 7, 2026

Record last verified: 2026-07

Locations

US (1)