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NCT Number: NCT07006714

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis Arthritis Avitaminosis Deficiency Diseases Joint Diseases Malnutrition Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Rheumatic Diseases Vitamin D Deficiency

Age range

18 year–96 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Hospital length of stay

    Time frame: Up to 90 days.

    Measured in hours.

  2. Number of medical complications

    Time frame: Up to 90 days.

    Measured in number.

  3. Number of readmission rates

    Time frame: Up to 90 days.

    Measured in number.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Preoperative Single High-Dose Vitamin D for Correcting Deficiency in Hip and Knee Arthroplasty Patients-A Prospective Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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