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

25871 Participants Needed

Trial Summary

What is the purpose of this trial?

The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 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 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.

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

Eligibility Criteria

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

No other serious illness that would preclude participation

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

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

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

Treatment Details

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.

Participant Groups

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+