Vitamin D + Omega-3 for Osteoporosis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Bisphosphonates, Bone-active medications

Disqualifiers: Cardiovascular disease, Cancer, Renal failure, others

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

25871 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires participants to stop taking fish oil supplements and limits calcium and vitamin D intake. If you are using bisphosphonates or other bone-active medications, you cannot participate.

What data supports the effectiveness of the treatment Vitamin D + Omega-3 for Osteoporosis?

Some studies suggest that omega-3 fatty acids might help improve bone mineral density, especially when combined with calcium, and vitamin D is commonly used to support bone health, although definitive evidence is still needed. ^{1 2 3 4 5}

Is the combination of Vitamin D and Omega-3 supplements safe for humans?

Research on Vitamin D and Omega-3 supplements, including studies like the VITamin D and OmegA-3 TriaL (VITAL), suggests they are generally safe for humans. These supplements have been studied for various health outcomes, and no major safety concerns have been reported in the trials. ^{1 5 6 7 8}

How does the Vitamin D + Omega-3 treatment for osteoporosis differ from other treatments?

This treatment is unique because it combines high-dose vitamin D3 and omega-3 fatty acids, which are typically used for other health benefits like heart health, to potentially improve bone health. Unlike standard osteoporosis treatments that often focus on calcium and vitamin D alone, this approach explores the added benefit of omega-3s, which may enhance bone density and structure. ^{1 4 5 9 10}

Research Team

Meryl S LeBoff, M.D.

Principal Investigator

Brigham and Women's Hospital

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.

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vitamin D supplementation or placebo for 2 years to assess changes in bone density and structure

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

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

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

Group III: Vitamin D + fish oil 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 Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review of omega-3 fatty acids and osteoporosis. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Polyunsaturated fatty acids. Is there a role in postmenopausal osteoporosis prevention? [2019]

3. England pubmed.ncbi.nlm.nih.gov

An investigation of the association between omega 3 FA and bone mineral density among older adults: results from the National Health and Nutrition Examination Survey years 2005–2008. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

VITAL-Bone Health: rationale and design of two ancillary studies evaluating the effects of vitamin D and/or omega-3 fatty acid supplements on incident fractures and bone health outcomes in the VITamin D and OmegA-3 TriaL (VITAL). [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

[Osteoporosis and the intake of meat and fish]. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Modulatory effect of cod liver oil on bone mineralization in overiectomized female Sprague Dawley rats. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Inhibition of osteoporosis due to restricted food intake by the fish oils DHA and EPA and perilla oil in the rat. [2013]