Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications
Hip Arthropathy, Knee Arthropathy, Vitamin D Deficiency
About this trial
This is an interventional prevention trial for Hip Arthropathy focused on measuring joint replacement, hip arthroplasty, knee arthroplasty, clinical outcomes, Vitamin D Deficiency
Eligibility 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
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
No Intervention
Low Vitamin D3 Supplementation
High Vitamin D3 Supplementation
No supplementation
Subjects enrolled into Group 1 (low-dose Vitamin D3 supplementation) will receive 800 IU of oral Vitamin D3 (Cholecalciferol) daily for 4 weeks prior to surgery, followed by 800 IU of oral Vitamin D3 daily for 3 months after surgery. Vitamin D3 supplementation will be given for a total of 4 months. Supplementing Vitamin D-deficient patients with a minimum of 800 IU of Vitamin D3 daily is supported by the IOM.
Subjects enrolled into Group 2 (high-dose Vitamin D3 supplementation) will receive 50,000 IU of oral Vitamin D3 (Cholecalciferol) twice per week for 1 weeks followed by 50,000 IU once per week for 3 weeks prior to surgery. After surgery they will receive 50,000 IU of oral Vitamin D3 once per week for 4 weeks followed by 800 IU daily for 8 weeks. Vitamin D3 supplementation will be given for a total of 4 months.
Subjects with serum 25(OH)D level ≥30ng/mL will not receive any Vitamin D supplementation both pre- and postoperatively, as these are considered sufficient. These control patients will be asked to take any supplements containing Vitamin D for the duration of their participation in the trial. All patients in group 3 will have their serum 25(OH)D checked at 3 months after the surgery.