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

NCT07006714 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 20250203
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 90 days.

Secondary Outcomes (3)

• Hospital length of stay

  Up to 90 days.

• Number of medical complications

  Up to 90 days.

• Number of readmission rates

  Up to 90 days.

Study Arms (1)

Vitamin D Deficient Group

EXPERIMENTAL

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.

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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.

Vitamin D Deficient Group

Eligibility Criteria

• Age: 18 Years - 96 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Michele D'Apuzzo, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)