Vitamin D3 for Vitamin D Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a single high dose of vitamin D3 can reduce complications for individuals with low vitamin D levels undergoing joint replacement surgery. It targets those with vitamin D levels below 30 ng/mL who are preparing for surgery. Individuals who have not recently taken extra vitamin D and can provide consent may be suitable candidates. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for Vitamin D3?
Research has shown that vitamin D3, also known as cholecalciferol, is generally safe for people. A recent study found that a single high dose of vitamin D3 can reduce hospital deaths by half in patients with severe vitamin D deficiency, suggesting that high doses are well-tolerated by those who need it most.
Many studies on vitamin D supplements have examined safety. While these studies have not identified major safety issues, taking more than the recommended amount can sometimes cause side effects like nausea or weakness.
This trial is in Phase 4, indicating that vitamin D3 has undergone extensive study and is known to be safe. The FDA has also approved vitamin D3 for treating vitamin D deficiency, further supporting its safety for people.12345Why are researchers enthusiastic about this study treatment?
Vitamin D3 is unique because it directly addresses vitamin D deficiency by replenishing the body's levels with a single, high-dose administration. Unlike standard treatments that may require daily supplementation over an extended period, this approach offers a more immediate and efficient solution. Researchers are excited about its potential to quickly restore vitamin D levels, which could improve patient outcomes in those undergoing treatments like total joint arthroplasty.
What is the effectiveness track record for Vitamin D3 in reducing complications after TJA?
Research has shown that vitamin D3, which participants in this trial will receive, effectively raises low vitamin D levels in the body. Studies have found that it helps improve bone health by preventing fractures and falls. Vitamin D3 also boosts muscle strength and mobility. It is more effective than other types of vitamin D in increasing vitamin D levels in the blood. This treatment has proven effective in addressing vitamin D deficiency, which can lead to bone problems like rickets in children and weak bones in adults.12467
Who Is on the Research Team?
Michele D'Apuzzo, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for individuals with low vitamin D levels who are scheduled to undergo primary Total Joint Arthroplasty (TJA) due to osteoarthritis. Specific eligibility criteria details were not provided, so it's important for interested participants to contact the study team for full inclusion and exclusion criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single high-dose vitamin D supplement prior to undergoing standard of care total joint arthroplasty
Follow-up
Participants are monitored for complications such as prosthetic joint infection, hospital length of stay, medical complications, and readmission rates
What Are the Treatments Tested in This Trial?
Interventions
- Vitamin D3
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor