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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily supplements of vitamin D3 or fish oil (omega-3 fatty acids) can reduce breathing problems associated with COPD and asthma, such as frequent asthma attacks or pneumonia. Researchers aim to determine if these supplements can improve lung function and control asthma symptoms. The trial includes four groups, testing different combinations of vitamin D3 and fish oil or their placebos. It suits individuals already participating in the VITAL study and residing in specific U.S. cities where lung capacity can be tested. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of supplements for respiratory health.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that vitamin D3 helps people with moderate COPD breathe better and reduces the risk of severe flare-ups. Other research indicates that vitamin D can lower the chances of serious lung infections.

Omega-3 fatty acids, often found in fish oil, also show promise. Studies have linked higher omega-3 levels to better lung function and a reduced risk of COPD worsening. Regular fish oil intake appears to lower the chance of developing COPD initially.

Both vitamin D3 and fish oil are generally well-tolerated. Large group tests have added confidence in their safety. While every treatment can have side effects, evidence so far suggests these supplements are safe for most people. Always consult a healthcare provider before starting any new supplement. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for COPD, which often include bronchodilators and steroids to manage symptoms, the combination of Vitamin D3 and fish oil offers a unique approach by potentially addressing inflammation and immune function. Researchers are excited about these treatments because Vitamin D3 is known for its role in enhancing immune response, while omega-3 fatty acids in fish oil have anti-inflammatory properties. This combination targets underlying inflammation and immune regulation, which could lead to improved lung function and symptom management for COPD patients.

What evidence suggests that this trial's treatments could be effective for COPD?

Research has shown that vitamin D3 can help people with COPD by improving lung function and making exercise easier. Some studies suggest that vitamin D3 can also reduce flare-ups in those with low vitamin D levels. In this trial, one treatment arm will receive vitamin D3 along with fish oil.

Omega-3 fatty acids, found in fish oil, might also be beneficial. Higher omega-3 levels are linked to better quality of life and fewer flare-ups in COPD patients. Omega-3s may also protect the lungs from pollution damage. This trial will include a treatment arm where participants receive omega-3 fatty acids alone. These findings suggest that both vitamin D3 and omega-3 could benefit people with COPD. ^{1 2 6 7 8}

Who Is on the Research Team?

Diane R Gold, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8476109/

Effect of Omega-3 Fatty Acids on Chronic Obstructive ... Comparing with placebo, Omega-3 intake was associated with more weight-gaining, LDL increase and IL-6 reduction.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060334/

The effects of various nutritional supplements in patients with ... To evaluate the effectiveness of various nutritional supplements as interventions for patients with Chronic Obstructive Pulmonary Disease (COPD) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03796455

NCT03796455 | Fish Oil and HMB Supplementation in COPD Eicosapentaenoic acid (EPA), in combination with docosahexaenoic acid (DHA), has been shown to effectively inhibit weight loss in several disease states, ...

4. journal.copdfoundation.org journal.copdfoundation.org/jcopdf/id/1484/Higher-Plasma-Omega-3-Levels-are-Associated-With-Improved-Exacerbation-Risk-and-Respiratory-Specific-Quality-of-Life-in-COPD

Plasma Omega-3 Levels Associated With COPD Morbidity Higher plasma omega-3 levels are associated with improved exacerbation risk and respiratory-specific quality of life in COPD.

5. pubs.acs.org pubs.acs.org/doi/10.1021/envhealth.4c00198

Omega-3 Modify the Adverse Effects of Long-Term Exposure ... Circulating omega-3 PUFA may provide protection against the COPD risk caused by long-term exposure to air pollutants.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4307205/

Fish intake and risk of chronic obstructive pulmonary disease ... We examined the role of fish and PUFA intakes on risk of developing COPD while taking into account the overall dietary pattern.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0261561422003569

Habitual fish oil supplementation and incident chronic ... Habitual fish oil supplementation was significantly associated with a lower risk of incident COPD (adjusted HR: 0.88; 95% CI: 0.84–0.93). The association with ...

8. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202307-1222ED

The Protective Effect of Omega-3 Fatty Acids in Attenuating ... Omega-3 fatty acids have been associated with better lung function and reduced risk of COPD. However, results from cross-sectional studies of circulating ...