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

N/A
Waitlist Available
Led By Diane R Gold, MD, MPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Population includes men 50 years of age or older and women 55 years of age or older in the United States
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year

Summary

This trial is investigating whether taking daily dietary supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, common side effects from these supplements may include mild digestive issues for fish oil and too much calcium in the blood from high doses of Vitamin D3.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man over 50 or a woman over 55 living in the US.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chronic Airflow Obstruction
COPD exacerbations in the past year over the course of the study
Pneumonia in the past year over the course of the study
Secondary study objectives
Asthma exacerbations and asthma control in the past year over the course of the study

Trial Design

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

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,852,395 Total Patients Enrolled
Harvard School of Public Health (HSPH)OTHER
280 Previous Clinical Trials
14,095,663 Total Patients Enrolled
Diane R Gold, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Media Library

fish oil (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01728571 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: Vitamin D3 + fish oil, Vitamin D3 placebo + fish oil placebo, Vitamin D3 placebo + fish oil, Vitamin D3 + fish oil placebo
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: fish oil Highlights & Side Effects. Trial Name: NCT01728571 — N/A
fish oil (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01728571 — N/A
~1678 spots leftby Dec 2025
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