Vitamin D + Omega-3 for Osteoporosis

Recruiting in Palo Alto (17 mi)

Overseen byMeryl S LeBoff, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

Trial Summary

What is the purpose of this trial?Vitamin D supplements are widely promoted for bone health. Both vitamin D and vitamin K are important for deposition of calcium in bone, but little is known about the relationship of vitamin K status and bone health.

Eligibility Criteria

This trial is for men over 50 and women over 55 without cardiovascular disease or cancer, except non-melanoma skin cancer. Participants should not consume more than 1200 mg of calcium or take fish oil supplements during the trial. They must also avoid high doses of vitamin D (over 800 IU). People with severe liver disease, kidney failure, certain hormonal disorders, or other serious illnesses cannot join.

Inclusion Criteria

I do not have allergies to soy or fish, severe kidney, liver, or parathyroid issues, sarcoidosis, or other serious illnesses.

Participants in VITAL (NCT 01169259) study who met the following criteria of the parent trial are eligible to participate in this ancillary study:

I have no history of heart disease or cancer, except for non-melanoma skin cancer.

+4 more

Exclusion Criteria

I haven't taken bisphosphonates or other bone medications in the past year.

Participant Groups

The VITAL study examines how Vitamin D3 and Omega-3 fatty acids (fish oil) affect bone health in older adults. It's testing whether these supplements can help prevent osteoporosis and broken bones by improving calcium deposition in bones.

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D + fish oil placeboActive Control2 Interventions

Group II: Vitamin D placebo + fish oilActive Control2 Interventions

Group III: Vitamin D + fish oilActive Control2 Interventions

Group IV: Vitamin D placebo + fish oil placeboPlacebo Group2 Interventions