Recruiting

Vitamin D

Sponsor:

Brigham and Women's Hospital

Code:

NCT04229368

Conditions

Hip Arthropathy

Knee Arthropathy

Vitamin D Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin D3

Study Details

Brief summary:

Vitamin D status has been shown to have an effect on post-operative outcomes in total joint arthroplasty. The goal of this study is to determine if pre-operative supplementation and correction of Vitamin D deficiency can reduce postoperative complications.

Conditions

Hip Arthropathy

Knee Arthropathy

Vitamin D Deficiency

Study ID

NCT04229368

Start date

Sep 1, 2019

Status verified date

Aug, 2023

Completion date

Jul 1, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Low Vitamin D3 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.

active comparator: High Vitamin D3 Supplementation

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.

no intervention: No supplementation

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.

Interventions

Vitamin D3

Vitamin D will be given at doses commonly given to patients with low vitamin D levels

Primary outcome measure

  • Readmission, reoperation, wound complications, and PJI [ Time Frame: Preoperative visit to three months post-op ]

Central Contacts and Locations

Central contacts

Antonia F Chen, MD

617-525-5935afchen@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Antonia F Chen, MD, MBA

617-525-5935afchen@bwh.harvard.edu

Principal Investigator:

Antonia F Chen, MD, MBA

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 16, 2023

Last verified

Aug, 2023

Keywords

  • joint replacement
  • hip arthroplasty
  • knee arthroplasty
  • clinical outcomes
  • Vitamin D Deficiency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2023-08-16.