Vitamin D + Omega-3 for Osteoporosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how vitamin D and omega-3 fatty acids (fish oil) might support bone health, especially for those concerned about osteoporosis, a condition where bones become weak and brittle. Researchers aim to determine if these supplements aid in calcium deposition in bones. Participants will receive various combinations of vitamin D, fish oil, or placebos to identify the most effective option. This trial suits individuals who participated in the VITAL study, are over a certain age, and have no history of major diseases like cardiovascular disease or cancer. Participants should not take certain bone medications and must limit their intake of calcium, vitamin D, and fish oil. As an unphased trial, this study provides a unique opportunity to contribute to understanding how these supplements might enhance 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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both vitamin D3 and omega-3 fatty acids are generally safe and well-tolerated. One study found that vitamin D3 did not significantly reduce fracture risk but also did not cause major side effects. Another study indicated that omega-3 supplements might lower fracture risk without causing serious issues.
Clinical trials have demonstrated that vitamin D3 supports bone health and is safe for regular use at recommended doses. Omega-3 fatty acids, often found in fish oil, are linked to a reduced risk of osteoporosis, a condition where bones become weak.
Overall, research suggests that taking vitamin D3 and omega-3s together is safe. However, following dosing guidelines and consulting with a healthcare provider is important, as with any supplement.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using Vitamin D and Omega-3 fatty acids for osteoporosis because these natural compounds may offer a different approach compared to traditional medications like bisphosphonates or hormone replacement therapy. Unlike most treatments that primarily focus on slowing bone loss, Vitamin D and Omega-3 have the potential to support bone health by enhancing calcium absorption and reducing inflammation, respectively. This combination could offer a more holistic way to maintain or even improve bone density, making it a promising alternative for those seeking dietary supplements over pharmaceuticals.
What evidence suggests that this trial's treatments could be effective for osteoporosis?
This trial will compare the effects of Vitamin D3 and omega-3 supplements on bone health. Research has shown that these supplements do not significantly improve bone health or reduce fractures. Specifically, studies found that vitamin D3 supplements had little impact on bone strength or fracture risk. Similarly, omega-3 supplements did not enhance bone strength or structure. However, some evidence suggests that consuming more foods rich in omega-3s might be linked to a lower risk of osteoporosis, a condition where bones become weak and brittle. Overall, the benefits of these supplements for bone health remain unclear based on current research.12367
Who Is on the Research Team?
Meryl S LeBoff, M.D.
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vitamin D supplementation or placebo for 2 years to assess changes in bone density and structure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fish oil placebo
- Omega-3 fatty acids (fish oil)
- Vitamin D3
- Vitamin D3 placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator