Omega-3 + Vitamin D for High Blood Pressure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Hypertension, Cancer, Heart disease, Stroke

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

Compensation: Varies

Number of Visits: 1

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if daily supplements of vitamin D3 and omega-3 fatty acids (fish oil) can lower the risk of developing high blood pressure. Researchers seek to discover if these supplements can also reduce the risk of cancer, heart disease, or stroke in individuals without these conditions. Participants will be divided into groups to receive either the actual supplements or placebos. Individuals who have never been diagnosed with high blood pressure and live in certain U.S. cities might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding the preventive benefits of common supplements.

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

Research has shown that omega-3 fatty acids (found in fish oil) and vitamin D3 are generally safe for most people. Studies suggest that fish oil is safe in doses of 3 grams or less per day, while higher doses may increase bleeding risk. Some studies also mention rare risks, such as heavy metal contamination.

For vitamin D3, research indicates that daily doses between 1,000 to 5,000 IU are usually safe. However, excessive intake can lead to high calcium levels in the blood, known as hypercalcemia, which is less likely if recommended doses are followed.

Overall, both treatments are well-tolerated. Consulting a healthcare provider before starting new supplements is advised, especially if other medications are being taken. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Omega-3 fatty acids and Vitamin D for high blood pressure because these treatments offer a natural alternative to standard medications like ACE inhibitors or beta-blockers. Omega-3 fatty acids, derived from fish oil, may help reduce inflammation and improve heart health, which could lower blood pressure. Vitamin D, known for its role in bone health, might also play a part in regulating blood pressure by affecting calcium levels and vascular function. Unlike traditional treatments, which often come with side effects, these supplements are generally well-tolerated, making them an appealing option for those seeking more natural ways to manage their blood pressure.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

This trial will evaluate the effects of Omega-3 fatty acids and Vitamin D-3 on high blood pressure. Studies have shown that omega-3 fatty acids can help lower blood pressure, with about 3 grams daily linked to a reduction of approximately 4.5 mmHg in the systolic reading. Although the optimal amount for lowering blood pressure is between 2 to 3 grams per day, this trial uses only 1 gram, which might have a smaller effect.

Research has indicated that vitamin D-3 does not consistently lower blood pressure in most people, although some studies suggest it might help at higher doses over shorter periods. The evidence is mixed, and while some results are promising, vitamin D-3 alone may not be very effective in lowering blood pressure. Participants in this trial will receive either a combination of Vitamin D and fish oil, Vitamin D with a fish oil placebo, fish oil with a Vitamin D placebo, or both placebos to assess the effects on blood pressure. ^{2 6 7 8 9}

Who Is on the Research Team?

Howard D. Sesso, ScD, MPH

Principal Investigator

Brigham and Women's Hospital

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?

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+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial of omega-3 fatty acids for prevention of hypertension. Dokholyan, RS., Albert, CM., Appel, LJ., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9238708/

Omega‐3 Polyunsaturated Fatty Acids Intake and Blood ... This dose‐response meta‐analysis demonstrates that the optimal combined intake of omega‐3 fatty acids for BP lowering is likely between 2 g/d and 3 g/d.

2. heart.org heart.org/en/news/2022/06/01/consuming-about-3-grams-of-omega-3-fatty-acids-a-day-may-lower-blood-pressure

Consuming about 3 grams of omega-3 fatty acids a day ... For people with high blood pressure, 3 grams of omega-3 fatty acids a day lowered systolic blood pressure by an average 4.5 mmHg. In those ...

3. mayoclinic.org mayoclinic.org/drugs-supplements-fish-oil/art-20364810

Fish oil High blood pressure. Multiple studies report modest reductions in blood pressure in people who take fish oil supplements. There's some evidence that the ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.026258

Blood Pressure–Lowering Effects of Omega‐3 ... As described by Zhang et al, the intake of ω3 PUFAs is associated with a BP‐lowering effect, and a dose of 2 to 3 g appears to be optimal. Given ...

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

Regular use of fish oil supplements and course ... In terms of composition of omega 3 fatty acids, a recent meta-analysis showed that eicosapentaenoic acid alone can be more effective at reducing the risk of ...

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Many studies have assessed the effects of omega-3s—primarily EPA and DHA—on CVD and CVD risk factors, such as high blood pressure and elevated plasma lipids.

7. nhlbi.nih.gov nhlbi.nih.gov/news/2024/omega-3s-heart-health-exploring-potential-benefits-and-risks

Omega-3s for heart health? Exploring potential benefits and ... Some studies suggest that there are potential risks associated with fish oil supplements. Those risks include heavy metal contamination, such as ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.025071

Omega‐3 Polyunsaturated Fatty Acids Intake and Blood ... Doses of omega‐3 fatty acid intake above the recommended 3 g/d may be associated with additional benefits in lowering BP among groups at high ...

9. webmd.com webmd.com/vitamins/ai/ingredientmono-993/fish-oil

Fish Oil - Uses, Side Effects, and More When taken by mouth: Fish oil is likely safe for most people in doses of 3 grams or less daily. Taking more than 3 grams daily might increase the chance of ...