Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 96 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07006714
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Miami
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michele D'Apuzzo, MD
Principal Investigator Affiliation University of Miami
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Vitamin D Deficiency
Arms & Interventions

Arms

Experimental: Vitamin D Deficient Group

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.

Interventions

Drug: - Vitamin 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Miami, Miami 4164138, Florida 4155751

Status

Address

University of Miami

Miami 4164138, Florida 4155751, 33136

Site Contact

Antonio Fernandez-Perez, MSc

[email protected]

3056895195

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