25875 Participants Needed

Omega-3 + Vitamin D for High Blood Pressure

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
Stay on Your Current MedsYou can continue your current medications while participating

What You Need to Know Before You Apply

What is the purpose of this trial?

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The VITAL Hypertension ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids are related to changes in blood pressure and hypertension.

Will I have to stop taking my current medications?

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 it safe to take omega-3 and vitamin D supplements for high blood pressure?

Omega-3 supplements, like fish oil, are generally safe for most people, but they can cause side effects like nausea, diarrhea, and a 'fishy' taste. They may also increase bleeding times and affect platelet levels, so it's important to use them carefully. Vitamin D supplements are usually safe at recommended doses, but taking too much can lead to health issues.12345

How is the Omega-3 and Vitamin D treatment for high blood pressure different from other treatments?

This treatment is unique because it combines Omega-3 fatty acids, which have shown potential in lowering blood pressure, with Vitamin D, which is not commonly used for this purpose. The combination of these two supplements may offer a novel approach to managing high blood pressure compared to traditional medications.16789

What data supports the effectiveness of the treatment Omega-3 fatty acids (fish oil) and Vitamin D-3 for high blood pressure?

Research suggests that omega-3 fatty acids, found in fish oil, can help lower blood pressure, especially in people with mild high blood pressure. However, more studies are needed to fully understand their benefits and how they work with other treatments.1261011

Who Is on the Research Team?

HD

Howard D. Sesso, ScD, MPH

Principal Investigator

Brigham and Women's Hospital

JP

John P. Forman, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

The VITAL Hypertension trial is for U.S. adults without a history of high blood pressure, cancer, heart disease, or stroke who are already part of the main VITAL study. It's focused on those willing to take daily supplements and located in certain cities where home visits can be conducted.

Inclusion Criteria

Participants eligible and willing to participate in the main VITAL trial (NCT 01169259)
Participants living in selected cities throughout the U.S. for home visits in the subcohort of 1,000 participants
You do not have a history of high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including 24-hour ABP measurements, fasting bloods, and spot urine samples

1 visit
1 home-based visit

Treatment

Participants receive daily dietary supplements of vitamin D3 or omega-3 fatty acids or placebo

2 years

Follow-up

Participants are monitored for changes in blood pressure and new diagnoses of hypertension

5 years
Annual follow-up questionnaires

What Are the Treatments Tested in This Trial?

Interventions

  • Omega-3 fatty acids (fish oil)
  • Vitamin D-3 (cholecalciferol), 2000 IU
Trial Overview This study tests if daily vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can lower the risk of developing high blood pressure. Participants are randomly assigned to receive either one of these supplements or a placebo.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

Omega-3 fatty acids, commonly found in fish oil, have been associated with lower incidences of diseases like coronary heart disease and diabetes, likely due to their effects on inflammation and blood viscosity.
While omega-3 supplementation appears to be relatively safe, potential risks include increased bleeding times and gastrointestinal issues, highlighting the need for further long-term studies to confirm their therapeutic benefits.
Biological mechanisms and cardiovascular effects of omega-3 fatty acids.Mueller, BA., Talbert, RL.[2022]
A randomized trial tested a novel fatty acid supplement in patients with high normal diastolic blood pressure, but it did not significantly lower blood pressure levels.
While omega-3 polyunsaturated fatty acids are known to reduce blood pressure, the new supplement did not show the same efficacy, suggesting it may not be a suitable alternative for managing blood pressure in this population.
A trial of omega-3 fatty acids for prevention of hypertension.Dokholyan, RS., Albert, CM., Appel, LJ., et al.[2013]

Citations

Can we recommend fish oil for hypertension? [2019]
Does supplementation of diet with 'fish oil' reduce blood pressure? A meta-analysis of controlled clinical trials. [2020]
Long-chain omega-3 fatty acids and blood pressure. [2021]
Blood pressure-lowering effects of long chain n-3 fatty acids from meals enriched with liquid fish oil and from microencapsulated powder. [2018]
Fish and omega-3 fatty acid consumption and risk of hypertension. [2020]
Biological mechanisms and cardiovascular effects of omega-3 fatty acids. [2022]
Different effects of eicosapentaenoic acid and olive oil on blood pressure, intracellular free platelet calcium, and plasma lipids in patients with essential hypertension. [2019]
A trial of omega-3 fatty acids for prevention of hypertension. [2013]
The long-term effect of advice to eat more fish on blood pressure in men with coronary disease: results from the diet and reinfarction trial. [2019]
Whole blood omega-3 fatty acid concentrations are inversely associated with blood pressure in young, healthy adults. [2023]
Epidemiological and intervention studies on the effect of marine polyunsaturated fatty acids on blood pressure. [2022]
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