Osteoarthritis, Vitamin D Deficiency
Conditions
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.
Interventions
DRUGVitamin D3
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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 96 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed