Vitamin D + Omega-3 for Osteoporosis and Body Composition
(VITAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to determine if vitamin D and fish oil supplements can improve bone health and body composition. Researchers seek to discover whether these supplements can reduce the risk of osteoporosis, a condition that weakens bones and increases fracture risk. The trial compares various combinations of vitamin D (also known as Vitamin D3 or Cholecalciferol) and omega-3 fatty acids (fish oil) against placebos (inactive substances) to identify the most effective option. It seeks participants who are not currently or recently taking medications for bone health. Individuals concerned about osteoporosis and not using these medications may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to understanding the potential benefits of supplements on bone health.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are using bisphosphonates or other bone-active medications, you are not eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, researchers examined how vitamin D3 and omega-3 fatty acids affect bone health and other outcomes. They compared these supplements to a placebo (a pill with no active ingredients). The results showed that participants tolerated vitamin D3 and omega-3 fatty acids well, with no significant differences in side effects between the supplement and placebo groups.
Another study focused on older adults and found that combining vitamin D3 and omega-3s might have positive health effects without major side effects. Participants did not report serious negative effects from the supplements, suggesting they are safe to use.
Overall, evidence indicates that both vitamin D3 and omega-3 fatty acids are generally safe and well-tolerated, usually not causing harmful side effects in those who take them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using vitamin D and omega-3 fish oil for osteoporosis and body composition because these supplements offer a natural approach with potential benefits beyond traditional medications. Unlike typical osteoporosis treatments like bisphosphonates or hormone-related therapies, vitamin D is crucial for calcium absorption, which is vital for bone health, while omega-3s are known for their anti-inflammatory properties. This combination could not only help strengthen bones but also improve overall body composition, potentially offering a dual benefit in a simple daily regimen.
What evidence suggests that this trial's treatments could be effective for osteoporosis and body composition?
This trial will evaluate the effects of Vitamin D3 and omega-3 fatty acids, found in fish oil, on bone health and body composition. Research has shown mixed results for these supplements in improving bone health. Participants will be assigned to different treatment arms: one group will receive both Vitamin D3 and fish oil, another will receive Vitamin D3 with a fish oil placebo, a third group will receive fish oil with a Vitamin D3 placebo, and a final group will receive placebos for both. Studies suggest that omega-3s may help protect against bone density loss, especially in people with high blood pressure. However, one study found that Vitamin D3 alone, without added calcium, did not significantly improve bone health over two years. While omega-3s have shown some promise in helping bone formation and reducing bone loss, the evidence for Vitamin D3 is less clear, with some studies showing no significant impact on bone density. Overall, the combination of Vitamin D3 and omega-3s might offer potential benefits, but more research is needed to confirm their effectiveness in improving bone health.678910
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline measurements of bone density, bone turnover, and body composition are performed
Treatment
Participants receive daily dietary supplements of vitamin D3 or fish oil, or placebos, for 2 years
Follow-up
Participants are monitored for changes in bone density, bone turnover, and body composition 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
Vitamin D3 is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
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