Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA)

Phase 4

Not yet recruiting

• Conditions: Osteoarthritis; Vitamin D Deficiency
• Interventions: Drug: Vitamin D3

• Registration Number: NCT07006714
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is being conducted to determine whether correcting low levels of vitamin D with a single high-dose supplement reduces complications after the participant's primary TJA.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Study Start: 2025-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Serum 25(OH)D < 30 ng/mL within 2 weeks of surgery.
• Able to provide informed consent.

Exclusion Criteria

• Follow-up duration < 90 days anticipated.
• Acute hepatitis, cancer, organ transplant recipients, or dialysis patients.
• Extra vitamin D supplementation within 90 days post-surgery.
• Preoperative serum 25(OH)D ≥ 30 ng/mL.
• Adults unable to consent (excluded).
• Individuals under 18 (excluded).
• Pregnant women (excluded).
• Prisoners (excluded).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D Deficient Group	Vitamin D3	Participants who are vitamin D deficient and undergo standard of care TJA will receive a single dose of vitamin D. Total participation for up to 90 days.

Primary Outcome Measures

Name	Time	Method
Prosthetic joint infection as measured by the Musculoskeletal Infection Society (MSIS) criteria.	Up to 90 days.	The MSIS criteria infection scores range from 0-1 as not infected, 2-5 as possibly infected, and 6 or greater than 6 as infected.

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	Up to 90 days.	Measured in hours.
Number of medical complications	Up to 90 days.	Measured in number.
Number of readmission rates	Up to 90 days.	Measured in number.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States