Vitamin D + Omega-3 for Osteoporosis and Body Composition

(VITAL Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Bisphosphonates, Bone-active medications

Disqualifiers: Cancer, Heart disease, Stroke, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 104 weeks

771 Participants Needed

Trial Summary

What is the purpose of this trial?

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) 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 fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among a sub-cohort of 771 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.

Research Team

Meryl S LeBoff, M.D.

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

The VITAL trial is for U.S. men and women who are part of the larger VITAL study, have no history of cancer, heart disease, or stroke, and aren't on bone-active medications currently or within the past year (or bisphosphonates within 2 years).

Exclusion Criteria

I haven't used bisphosphonates or other bone medications in the required time frame.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of bone density, bone turnover, and body composition are performed

1 visit

1 visit (in-person)

Treatment

Participants receive daily dietary supplements of vitamin D3 or fish oil, or placebos, for 2 years

104 weeks

Follow-up

Participants are monitored for changes in bone density, bone turnover, and body composition after treatment

4 weeks

Treatment Details

Interventions

• Fish oil placebo
• omega-3 fatty acids (fish oil)
• Vitamin D3
• Vitamin D3 placebo

Trial Overview This trial tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of serious diseases like cancer and heart disease in healthy individuals.

Participant Groups

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

Daily vitamin D (2,000 IU/d) and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)

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

Daily vitamin D placebo and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)

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

Daily vitamin D (2,000 IU/d) and daily fish oil placebo

Group IV: Vitamin D placebo + fish oil placebo Placebo Group 2 Interventions

Daily vitamin D placebo and daily fish oil placebo

Vitamin D3 is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in United States as Vitamin D3 for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in Canada as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in Japan as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in China as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Approved in Switzerland as Cholecalciferol for:

• Rickets
• Osteomalacia
• Hypoparathyroidism
• Vitamin D deficiency

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+