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Omega-3 Fatty Acid

Vitamin D3 + Omega-3 for Atrial Fibrillation

Phase 3

Waitlist Available

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

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

Study Summary

This trial is looking at whether taking daily supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke. They will also be looking at whether these agents might impact the development of atrial fibrillation and explore effects on arrhythmic death.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from taking vitamin D3 may include high calcium levels, kidney stones, and nausea. Omega-3s might cause unpleasant taste, bad breath, headaches, gastrointestinal symptoms like diarrhea and may increase bleeding risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Arrhythmic endpoints

Atrial Fibrillation

Other outcome measures

Sudden Cardiac Death

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D + fish oilActive Control2 Interventions

Group II: Vitamin D placebo + fish oilActive Control2 Interventions

Group III: Vitamin D + fish oil placeboActive Control2 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,611 Previous Clinical Trials

11,445,400 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,285,523 Total Patients Enrolled

Christine M. Albert, M.D., M.P.H.Principal InvestigatorBrigham and Women's Hospital

Media Library

Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT02178410 — Phase 3

Cardiovascular Disease Research Study Groups: Vitamin D placebo + fish oil placebo, Vitamin D + fish oil, Vitamin D placebo + fish oil, Vitamin D + fish oil placebo

Cardiovascular Disease Clinical Trial 2023: Omega-3 fatty acids (fish oil) Highlights & Side Effects. Trial Name: NCT02178410 — Phase 3

Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02178410 — Phase 3

Frequently Asked Questions

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

What is the enrollment size for this particular clinical trial?

"Currently, this clinical trial is not looking for any participants. The study was first posted on October 1st 2012 and the most recent update was on July 19th 2022. However, there are other studies which may be of interest. There are 444 trials actively recruiting patients with cardiovascular diseases and 18 studies involving Vitamin d + fish oil that are currently admitting patients."

Answered by AI

What is the precedent for using Vitamin D and fish oil together in a trial like this?

"There are a total of 18 clinical studies currently underway to research the efficacy of Vitamin d + fish oil. 4 of these trials have reached Phase 3. The majority of the related clinical trials are being conducted in Boston, Massachusetts; however, there are 35 locations running similar tests."

Answered by AI

Has the FDA cleared Vitamin D + fish oil for public consumption?

"There is some evidence to support the efficacy of Vitamin d + fish oil, and it has undergone multiple rounds of testing to ensure its safety. We rate it a 3 on our Power scale."

Answered by AI

Recent research and studies

JamaJournal

Effect of Marine Omega-3 Fatty Acid and Vitamin D Supplementation on Incident Atrial Fibrillation

Albert, Christine M., Nancy R. Cook, Julie Pester, M. Vinayaga Moorthy, Claire Ridge, Jacqueline S. Danik, Baris Gencer, et al.. 2021. “Effect of Marine Omega-3 Fatty Acid and Vitamin D Supplementation on Incident Atrial Fibrillation”. Jama. American Medical Association (AMA). doi:10.1001/jama.2021.1489.

clinicaltrials.govStudy

VITAL Rhythm Study

Christine M. Albert, MD, MPH 2012. "VITAL Rhythm Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02178410.

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