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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

Awards & highlights

lungVITAL Trial 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.Check my eligibility

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.See study design

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.

lungVITAL Trial 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.

lungVITAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Asthma exacerbations and asthma control in the past year over the course of the study

lungVITAL 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,608 Previous Clinical Trials

11,444,006 Total Patients Enrolled

Harvard School of Public Health (HSPH)OTHER

272 Previous Clinical Trials

16,279,141 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment currently available?

"As per clinicaltrials.gov, this experiment is no longer in the process of recruiting patients. Initially posted on July 1st 2010 and last updated August 11th 2021, this trial does not require participants at present but there are 729 other trials seeking volunteers currently."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

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

Gold, Diane R., Augusto A. Litonjua, Vincent J. Carey, JoAnn E. Manson, Julie E. Buring, I-Min Lee, David Gordon, et al.. 2016. “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”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2016.01.003.

clinicaltrials.govStudy

LungVITamin D and OmegA-3 Trial (lungVITAL)

Diane Gold 2010. "LungVITamin D and OmegA-3 Trial (lungVITAL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01728571.

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