Impact of Vitamin D on recovery after joint replacement surgery
Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications
NA · Brigham and Women's Hospital · NCT04229368
This study is testing if giving Vitamin D to patients before hip or knee replacement surgery can help them recover better and avoid complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04229368 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of Vitamin D status and supplementation in reducing postoperative complications for patients undergoing total joint arthroplasty (TJA) for hip or knee arthropathy. It aims to determine if correcting Vitamin D deficiency before surgery can lead to better clinical outcomes. The study will involve adult patients who meet specific eligibility criteria, including having a certain level of Vitamin D in their blood. Participants will receive Vitamin D3 supplementation as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective unilateral primary total joint arthroplasty and have a pre-operative serum 25(OH)D level of at least 10 ng/mL.
Not a fit: Patients with severe Vitamin D deficiency (serum 25(OH)D levels below 10 ng/mL), those undergoing revision surgeries, or individuals with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and fewer complications for patients undergoing joint replacement surgery.
How similar studies have performed: Previous studies have indicated that Vitamin D deficiency negatively impacts surgical outcomes, suggesting that this approach may be beneficial, although the specific intervention in this study is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients ≥18 years of age undergoing elective unilateral primary TJA for osteoarthritis * Patients with a pre-operative serum 25(OH)D levels ≥10 ng/mL * Patients who consent to the study Exclusion Criteria: * Adult patients ≥18 years of age undergoing elective primary TJA with a pre-operative serum 25(OH)D2,3 level \<10 ng/mL * Patients undergoing revision surgery * Patients lacking mental capacity to comply with study procedures * Patients with serum 25(OH)D levels between 10-29 ng/dL refusing to stop their current Vitamin D and multivitamins supplementations * Hypercalcemia (total calcium \>10.6 mg/dL or ionized serum calcium \>5.4mg/dL) * History of nephrolithiasis * Granulomatous disease * Dialysis and advanced kidney disease * Previous infection/septic arthritis * Inability to swallow Vitamin D3 pills * Allergy to Vitamin D3 (It is estimated that 1 in 300 individuals may have an allergy with skin manifestations 17) * Hypocalcemia (\<8.5 mg/dL) * Chronic kidney disease (eGFR \<60 mL/minute) * Known hyperparathyroidism * Known osteoporosis/insufficiency stress fractures (if normal stresses are applied to an abnormal bone) * Pregnancy
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Antonia F Chen, MD — Brigham and Women's Hospital
- Study coordinator: Antonia F Chen, MD
- Email: afchen@bwh.harvard.edu
- Phone: 617-525-5935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hip Arthropathy, Knee Arthropathy, Vitamin D Deficiency, joint replacement, hip arthroplasty, knee arthroplasty, clinical outcomes