Vitamin D3 + Omega-3 for COPD

(lungVITAL Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Cancer, Heart disease, Stroke, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

25871 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Diane R Gold, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

The lungVITAL trial is for men over 50 and women over 55 in the U.S. who are part of the VITAL study (NCT 01169259) and live in specific areas where clinic or home visits can be conducted. It's not open to those with a history of cancer, heart disease, or stroke.

Inclusion Criteria

This study is open to all VITAL participants (NCT 01169259)

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.

I am a man over 50 or a woman over 55 living in the US.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily dietary supplements of vitamin D3 or omega-3 fatty acids

5 years

Annual visits for follow-up assessments

Follow-up

Participants are monitored for respiratory morbidity, including COPD and asthma exacerbations, and other outcomes

5 years

Annual follow-up visits

Treatment Details

Interventions

• fish oil
• Vitamin D3

Trial Overview This trial tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce respiratory problems like COPD and asthma attacks, lower pneumonia risk, prevent airflow obstruction/decline in lung function, and improve asthma control.

Participant Groups

Group I: Vitamin D3 + fish oil Active Control 2 Interventions

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

Group II: Vitamin D3 placebo + fish oil Active Control 2 Interventions

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

Group III: Vitamin D3 + fish oil placebo Active Control 2 Interventions

Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo

Group IV: Vitamin D3 placebo + fish oil placebo Placebo Group 2 Interventions

Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+