OsteoarthritisPhase 4NCT07006714
Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA)
A Phase 4 study testing Vitamin D3 in people with Osteoarthritis and Vitamin D Deficiency, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 96 years
- Conditions the study is for
- Osteoarthritis, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 1 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 96 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum 25(OH)D < 30 ng/mL within 2 weeks of surgery.
- Able to provide informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Single High-Dose Vitamin D for Correcting Deficiency in Hip and Knee Arthroplasty Patients-A Prospective Study
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
- Being tested
- Vitamin D3
- Medical subject headings
- Osteoarthritis, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 days.
Secondary outcomes (3)
Hospital length of stay
Measured in hours.
Measured: Up to 90 days.
Number of medical complications
Measured in number.
Measured: Up to 90 days.
Number of readmission rates
Measured in number.
Measured: Up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start8 Sep 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele D'Apuzzo, University of Miami
- Investigators
- Michele D'Apuzzo, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006714
- Sponsor's protocol ID
- 20250203
- Status last verified
- Sep 2026
- First submitted
- 28 May 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Single High-Dose Vitamin D for Correcting Deficiency in Hip and Knee Arthroplasty Patients-A Prospective Study
- ClinicalTrials.gov ID
- NCT07006714
- Acronym / sponsor ID
- 20250203
- Conditions
- Osteoarthritis, Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Deficient Group | Experimental | Drug: Vitamin D3Participants 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. |
Who may qualify
- Ages
- 18 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Serum 25(OH)D < 30 ng/mL within 2 weeks of surgery.
- Able to provide informed consent.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Patients 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. | Drug | Vitamin D Deficient Group |
Primary outcome
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.
3 secondary outcomes
Hospital length of stay
Time frame: Up to 90 days.
Number of medical complications
Time frame: Up to 90 days.
Number of readmission rates
Time frame: Up to 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele D'Apuzzo, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 in people with Osteoarthritis and Vitamin D Deficiency, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic joint infection as measured by the Musculoskeletal Infection Society (MSIS) criteria. (time frame: Up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.