Vitamin D3 + Omega-3 for COPD
(lungVITAL Trial)

Recruiting in Palo Alto (17 mi)

Overseen byDiane R Gold, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

Stay on Your Current Meds

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.

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.

Treatment Details

Interventions

fish oil (Other)
Vitamin D3 (Other)

Trial OverviewThis 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

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D3 + fish oilActive Control2 Interventions

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

Group II: Vitamin D3 placebo + fish oilActive Control2 Interventions

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

Group III: Vitamin D3 + fish oil placeboActive Control2 Interventions

Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo

Group IV: Vitamin D3 placebo + fish oil placeboPlacebo Group2 Interventions

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