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

Phase 4Active Not RecruitingNCT07006714

University of Miami200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

200

Conditions

Osteoarthritis Vitamin D Deficiency

Interventions

Vitamin D3DRUG

Patients with a Vitamin D3 level of less than 30 nanograms per milliliter will receive a single oral (pill) dose of 300,000 international units of vitamin D3.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 96 Years

Medical Language ↔ Plain English

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).

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Prosthetic joint infection as measured by the Musculoskeletal Infection Society (MSIS) criteria.

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.

Time frame: Up to 90 days.

Secondary Outcomes

Hospital length of stay

Measured in hours.

Time frame: Up to 90 days.

Number of medical complications

Measured in number.

Time frame: Up to 90 days.

Number of readmission rates

Measured in number.

Time frame: Up to 90 days.

Data from ClinicalTrials.gov

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