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

University of Miami

Status and phase: Active, not recruiting; Phase 4

Conditions: Osteoarthritis; Vitamin D Deficiency

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT07006714

20250203

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 96 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Vitamin D Deficient Group

Experimental group

Description:

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.

Treatment:

Drug: Vitamin D3