Vitamin D + Omega-3 for Cancer and Cardiovascular Disease

(VITAL Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Brigham and Women's Hospital

Must not be taking: Fish oil, Vitamin D

Disqualifiers: Cancer, Heart disease, Stroke, others

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: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether vitamin D3 and omega-3 supplements can lower the risk of cancer, heart disease, and stroke. Participants will take either the supplements or placebos (inactive substances) to observe any differences in health outcomes. It targets individuals who have never had cancer, heart disease, or a stroke and who do not take high doses of vitamin D or fish oil supplements. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking health advancements.

Will I have to stop taking my current medications?

If you are taking more than 800 IU of vitamin D or 1200 mg of calcium from supplements, or any fish oil supplements, you will need to reduce or stop them during the trial.

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

Research has shown that omega-3 fatty acids, commonly found in fish oil, are generally safe for use. Studies have found they can improve heart health by lowering the risk of heart-related deaths. However, some research suggests a slight increase in the risk of an irregular heartbeat called atrial fibrillation in some users.

Regarding vitamin D3, research indicates it is usually well-tolerated. Some studies suggest that vitamin D3 might lower the risk of developing advanced cancer. There is no strong evidence of serious side effects from taking vitamin D3 supplements.

Both omega-3s and vitamin D3 have FDA approval for other uses, providing extra reassurance about their safety. Always consult a healthcare provider before starting any new supplement, especially when joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Vitamin D and Omega-3 fatty acids for cancer and cardiovascular disease because these natural substances might offer a safer and more holistic approach compared to traditional drugs like chemotherapy or statins. Unlike standard treatments that often come with significant side effects, Vitamin D and Omega-3 are generally well-tolerated and may support the body's natural defenses by reducing inflammation and promoting heart health. Furthermore, these treatments could potentially be easier to integrate into daily life as they are available in simple supplement forms. This combination could pave the way for a more preventative approach to managing these serious health conditions.

What evidence suggests that this trial's treatments could be effective for cancer and cardiovascular disease?

This trial will compare the effects of different combinations of Vitamin D3 and omega-3 fatty acids. Research has shown that omega-3 fatty acids, which some participants in this trial may receive, can improve heart health. Studies have found they can lower the risk of heart attacks and death from heart-related issues. However, omega-3s have not significantly reduced the risk of cancer. In contrast, vitamin D3, another treatment option in this trial, has not been proven to lower the risk of heart disease or cancer in general. Still, some evidence suggests it might reduce the risk of advanced cancer in individuals without a prior cancer diagnosis. Overall, omega-3s appear more promising for heart health, while vitamin D3 might help with advanced cancer risks. ^{1 3 4 5 6}

Who Is on the Research Team?

Julie E. Buring, ScD

Principal Investigator

Brigham and Women's Hospital

JoAnn E. Manson, MD, DrPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

The VITAL study is for U.S. adults without past heart disease, stroke, or cancer (except skin cancer). Men must be over 50 and women over 55. Participants shouldn't take more than small doses of vitamin D or calcium supplements, no fish oil supplements, and have no severe illnesses like kidney failure or liver disease.

Inclusion Criteria

Consuming no more than 800 IU of vitamin D from all supplemental sources combined, or willing to decrease or forego such use during the trial

I have not had cancer (except skin cancer), heart attack, stroke, or major heart procedures.

Consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or willing to decrease or forego such use during the trial

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 for primary prevention of cancer and cardiovascular disease

5 years

Annual questionnaires, occasional phone calls, and optional blood samples

Follow-up

Post-intervention observational follow-up of study participants is ongoing to monitor long-term effects

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Fish Oil Placebo
• Omega-3 Fatty Acids
• Vitamin D3
• Vitamin D3 Placebo

Trial Overview This trial tests if daily vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can prevent cancer, heart disease, and stroke in healthy individuals. It's a randomized study where participants unknowingly get either the real supplement or a placebo.

How Is the Trial Designed?

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

Group II: Vitamin D + 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+

Office of Dietary Supplements (ODS)

Collaborator

Trials

55

Recruited

54,500+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Pharmavite LLC

Industry Sponsor

Trials

12

Recruited

27,200+

Pronova BioPharma

Industry Sponsor

Trials

23

Recruited

31,700+

BASF

Industry Sponsor

Trials

14

Recruited

54,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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/PMC8413259/

Effect of omega-3 fatty acids on cardiovascular outcomes Omega-3 FAs reduced cardiovascular mortality and improved cardiovascular outcomes. The cardiovascular risk reduction was more prominent with EPA monotherapy ...

2. 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 ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1811403

Marine n−3 Fatty Acids and Prevention of Cardiovascular ... A 2014 meta-analysis of 10 trials of n−3 fatty acids showed a risk of cancer that was nonsignificantly higher, by 10%, with the n−3 fatty acids ...

4. ahajournals.org ahajournals.org/doi/10.1161/circoutcomes.112.966168

Omega 3 Fatty Acids and Cardiovascular Outcomes The results of this meta-analysis report that omega 3 fatty acids protect against vascular death, but there is no clear effect on total mortality, sudden death ...

5. academic.oup.com academic.oup.com/eurjpc/article/31/15/1863/7692830

Effects of omega-3 fatty acids on coronary revascularization ... Omega-3 FA supplementation was associated with reduced risk of MI (0.89, 95% CI 0.81–0.98; P = 0.02) and cardiovascular death (0.92, 95% CI 0.85 ...

6. 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 ... NHLBI feature article explores the potential benefits and risks of omega-3 supplements, including fish oil, for heart health.