Vitamin D3 + Omega-3 for Atrial Fibrillation

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Brigham and Women's Hospital

Disqualifiers: Atrial fibrillation prior, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether vitamin D3 or omega-3 fatty acids (fish oil) can reduce the risk of atrial fibrillation—an irregular and often rapid heart rhythm—in people without a history of cancer, heart disease, or stroke. Participants are randomly assigned to groups to receive either the supplements or placebos (inactive treatments) for comparison. The goal is to determine if these supplements can prevent atrial fibrillation and its subtypes. Those diagnosed with atrial fibrillation after joining the main Vitamin D and Omega-3 Trial might find this study suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the chance to contribute to potentially groundbreaking treatment advancements.

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?

Research has shown that vitamin D3 is generally safe for use. Some studies suggest that higher levels of vitamin D might reduce the risk of atrial fibrillation, an irregular and often fast heartbeat. However, other studies have found no effect on the risk of this condition.

The results for omega-3 fatty acids are mixed. Some research indicates that these supplements might increase the risk of atrial fibrillation, while other studies found no connection. Despite these concerns, omega-3s are often used for their heart health benefits.

Both vitamin D3 and omega-3 supplements have been studied for safety and are usually well-tolerated. They are available without a prescription, indicating safety for most people. However, consulting a healthcare provider before starting any new supplement is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Vitamin D3 and Omega-3 fatty acids for atrial fibrillation because these treatments offer a natural approach, potentially with fewer side effects than traditional medications like beta-blockers or anticoagulants. Unlike standard treatments, Omega-3s, found in fish oil, may have anti-inflammatory benefits that help stabilize heart rhythms. Vitamin D3 also supports heart health by potentially reducing inflammation and improving overall cardiovascular function. This combination could offer a complementary option to enhance heart health and manage atrial fibrillation more holistically.

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

This trial will evaluate the effects of omega-3 fatty acids and vitamin D3 on atrial fibrillation. Research has shown that these supplements do not significantly alter the risk of developing atrial fibrillation, an irregular heartbeat. One study found no major difference in atrial fibrillation occurrence between those who took the supplements and those who did not. In some cases, omega-3s might even slow the heart's electrical signals, possibly increasing the risk of atrial fibrillation. Similarly, vitamin D3 alone has not been shown to strongly reduce this risk. Overall, current evidence does not support these supplements as effective in preventing atrial fibrillation. Participants in this trial will be assigned to different arms, including combinations of vitamin D, fish oil, and placebos, to further investigate these findings. ^{3 4 5 6 7}

Who Is on the Research Team?

Christine M. Albert, M.D., M.P.H.

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

The VITAL Rhythm Study is for U.S. men and women without a history of cancer, heart disease, or stroke. Participants are being studied to see if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram) can prevent these diseases. Those with a physician diagnosis of atrial fibrillation after randomization or cardiovascular death are included.

Inclusion Criteria

- physician diagnosis of atrial fibrillation after randomization

and/or - cardiovascular death

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 questionnaires and outpatient/hospital visits for AF monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ECG analyses and blood sample evaluations

2 years

ECG at baseline and after 2 years

Extended Follow-up

Assessment of cumulative and post-treatment effects of omega-3 fatty acids and vitamin D on AF subtypes

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Omega-3 fatty acids (fish oil)
• Vitamin D3

Trial Overview This study tests whether taking daily dietary supplements—either vitamin D3 (2000 IU) or omega-3 fatty acids from fish oil (1 gram)—can lower the risk of developing serious health issues like cancer, heart disease, and stroke in people who haven't had these conditions before.

How Is the Trial Designed?

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

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

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

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10175873/

Omega-3 fatty acids and atrial fibrillation - PMC The large-scale RCTs of CV outcomes showed that omega-3 fatty acid supplementation was associated with increased risk of AF, particularly in trials that used ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.065769

Omega-3 Fatty Acids and Arrhythmias | Circulation The differential electrophysiologic effect of EPA and DHA on incident and recurrent atrial fibrillation are incompletely understood, and likely ...

3. bmjmedicine.bmj.com bmjmedicine.bmj.com/content/3/1/e000451

Regular use of fish oil supplements and course ... Conclusions Regular use of fish oil supplements might be a risk factor for atrial fibrillation and stroke among the general population but could be beneficial ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9109217/

Effect of long-term marine Omega-3 fatty acids ... In RCTs examining cardiovascular outcomes, marine omega-3 supplementation was associated with an increased risk of AF. The risk appeared to be greater in trials ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2023.05.024

Omega-3 Fatty Acid Biomarkers and Incident Atrial Fibrillation In vivo levels of omega-3 fatty acids including EPA, DPA, DHA, and EPA+DHA were not associated with increased risk of incident AF.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8756005/

Omega-3 supplementation linked with atrial fibrillation risk The researchers found that omega-3 fatty acid supplementation was associated with a significantly increased risk for atrial fibrillation compared to placebo, ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.058596

Fishing for Links Between Omega-3 Fatty Acids and Atrial ... Plant Omega-3 Fatty Acids May Lower Risk of Atrial Fibrillation in Individuals with a Low Intake of Marine Omega-3 Fatty Acids, The Journal ...