Knee OsteoarthritisPhase 4NCT04177758
Evaluating Vitamin D3 Supplement on Post-Op Outcomes
A Phase 4 study testing Vitamin D in people with Knee Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
Trial summary
The aim of this study is to determine if vitamin D supplementation is associated with differences in short-term recovery in patients following total knee arthroplasty compared to patients who do not receive supplementation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 1 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient undergoing primary total knee arthroplasty for osteoarthritis
- Age ≥ 18 years old
- Willingness to undergo randomization and return for all scheduled visits
Who cannot join
- Age > 80 years old
- American Society of Anesthesiologists (ASA) Score ≥ 4
- Other supplemental vitamin D or Calcium use including their analogs: ergocalciferol, calcitriol, dihydrotachysterol, and paricalcitol
- Current cancer
- Malabsorption syndromes
- Inability to take medications orally
- Renal impairment defined as a glomerular filtration rate (GFR) < 30 mL/minute or creatinine >1.3 mg/dL
- History of hypercalcemia defined as albumin-corrected hypercalcemia >12 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University medical Center
Chicago, Illinois, 60612
About this study
Official title: A Prospective, Tripled-Blinded, Randomized Controlled Trial Evaluating Vitamin D3 Supplementation on Post-Operative Functional and Clinical Outcomes Following Total Knee Arthroplasty
The aim of this study is to determine if vitamin D supplementation is associated with differences in short-term recovery in patients following total knee arthroplasty compared to patients who do not receive supplementation. If so, vitamin D supplementation has the potential to become widely incorporated into the routine care for patients undergoing knee replacements.
Read the detailed description
Patients will be enrolled from the clinics of Dr. Denis Nam and Dr. Craig Della Valle, two fellowship-trained orthopedic surgeons in the division of Adult Reconstruction at Midwest Orthopedics at Rush University Medical Center. Study staff will screen the clinic schedule of each surgeon and will discuss the purposes of the investigation at the time of their visit. If the patient is willing to participate in the investigation, verbal and written consent will be obtained by the study staff. At the time of consenting, patients will also be asked to perform a TUG test and will be asked to complete the questions that comprise the functional component of the KSS score.
This study will be tripled-blinded, thus, the patients, clinicians, and research staff involved will be unaware of patient allocation during this study. Each patient will receive a study ID, and a computer randomization system will be used to allocate patients to receive either vitamin D3 or placebo based on their study ID. Only members of the Rush pharmacy staff will possess the list matching the study ID to the study group assignment, ensuring that the study remains triple-blinded and that study coordinators are unaware of a patient's assignment when he or she picks up the study medication from the pharmacy.
Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D3 was selected over vitamin D2 as the former is less expensive and is more effective at raising serum 25-OH vitamin D levels than the latter. The regimen of 50,000IU given once was selected as this regimen has been previously used without side effects in previous studies and has been shown to be as effective as other regimens that utilize more frequent dosing with smaller doses. Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Both groups of patients will receive their medications from the pharmacy at Rush Medical Center, which will be responsible for providing patients with the appropriate regimen. All patients will receive the same postoperative multimodal analgesic regimen that is normally administered to patients undergoing THA and TKA at Rush University Medical Center.
In accordance with current standard post-operative care, patients will be asked to follow-up with their surgeon in clinic at 3 weeks and 6 weeks following surgery. At these post-operative visits, patients will be asked to repeat the TUG test and the 17-questions of the functional component of the KSS score.
- Conditions
- Knee Osteoarthritis
- Being tested
- Vitamin D, Control
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
ControlDrug
Patients randomized to the control will receive a placebo
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Receives: Drug: Control |
| Treatment | Experimental | Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score (KSS), Functional Component (2012) at 3 Weeks Post Operative
The functional component of the 2012 version of the knee society score at 3 weeks following surgery. Range 0-100. Assessed at 3 weeks following surgery, 3 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.
Measured: Assessed at 3 weeks following surgery
Knee Society Score (KSS) at 6 Weeks Following Surgery
The functional component of the 2012 version of the knee society score at 6 weeks following surgery. Range 0-100. Assessed at 6 weeks following surgery, 6 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.
Measured: Assessed at 6 weeks following surgery reported
Secondary outcomes (3)
Timed up and go Test at 3 Weeks Post Surgery
A timed up and go (TUG) test at 3 weeks following surgery. The TUG test consists of measuring the time it takes for an individual to rise from a seated position in a chair, walk to a mark 3 meters away, turn around, come back, and sit in the same chair from which they started. Patients will be asked to perform the test twice at each of the aforementioned encounters. The use of any assistive devices such as cane or a walker) will also be noted.
Measured: Assessed at 3 weeks following surgery
Timed up and go Test Difference From Baseline to 6 Weeks After Surgery
A timed up and go (TUG) test difference from baseline and at 6 weeks following surgery. The TUG test consists of measuring the time it takes for an individual to rise from a seated position in a chair, walk to a mark 3 meters away, turn around, come back, and sit in the same chair from which they started. Patients will be asked to perform the test twice at each of the aforementioned encounters. The use of any assistive devices such as cane or a walker) will also be noted.
Measured: value at 6 weeks minus value at baseline
Number of Participants With Complications
Occurrence of any of the Knee Society's Standardized List of Complications
Measured: 6 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Feb 2020
- Primary completion8 Oct 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Nam, M.D., M.Sc, Rush University Medical Center
- Investigators
- Denis Nam, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177758
- Sponsor's protocol ID
- 19092704
- Status last verified
- Mar 2023
- First submitted
- 22 Nov 2019
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Tripled-Blinded, Randomized Controlled Trial Evaluating Vitamin D3 Supplementation on Post-Operative Functional and Clinical Outcomes Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04177758
- Acronym / sponsor ID
- 19092704
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine if vitamin D supplementation is associated with differences in short-term recovery in patients following total knee arthroplasty compared to patients who do not receive supplementation. If so, vitamin D supplementation has the potential to become widely incorporated into the routine care for patients undergoing knee replacements.
Detailed description
Patients will be enrolled from the clinics of Dr. Denis Nam and Dr. Craig Della Valle, two fellowship-trained orthopedic surgeons in the division of Adult Reconstruction at Midwest Orthopedics at Rush University Medical Center. Study staff will screen the clinic schedule of each surgeon and will discuss the purposes of the investigation at the time of their visit. If the patient is willing to participate in the investigation, verbal and written consent will be obtained by the study staff. At the time of consenting, patients will also be asked to perform a TUG test and will be asked to complete the questions that comprise the functional component of the KSS score.
This study will be tripled-blinded, thus, the patients, clinicians, and research staff involved will be unaware of patient allocation during this study. Each patient will receive a study ID, and a computer randomization system will be used to allocate patients to receive either vitamin D3 or placebo based on their study ID. Only members of the Rush pharmacy staff will possess the list matching the study ID to the study group assignment, ensuring that the study remains triple-blinded and that study coordinators are unaware of a patient's assignment when he or she picks up the study medication from the pharmacy.
Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D3 was selected over vitamin D2 as the former is less expensive and is more effective at raising serum 25-OH vitamin D levels than the latter. The regimen of 50,000IU given once was selected as this regimen has been previously used without side effects in previous studies and has been shown to be as effective as other regimens that utilize more frequent dosing with smaller doses. Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Both groups of patients will receive their medications from the pharmacy at Rush Medical Center, which will be responsible for providing patients with the appropriate regimen. All patients will receive the same postoperative multimodal analgesic regimen that is normally administered to patients undergoing THA and TKA at Rush University Medical Center.
In accordance with current standard post-operative care, patients will be asked to follow-up with their surgeon in clinic at 3 weeks and 6 weeks following surgery. At these post-operative visits, patients will be asked to repeat the TUG test and the 17-questions of the functional component of the KSS score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: ControlPatients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. |
| Treatment | Experimental | Drug: Vitamin DPatients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient undergoing primary total knee arthroplasty for osteoarthritis
- Age ≥ 18 years old
- Willingness to undergo randomization and return for all scheduled visits
Key exclusion criteria (8 listed)
- Age > 80 years old
- American Society of Anesthesiologists (ASA) Score ≥ 4
- Other supplemental vitamin D or Calcium use including their analogs: ergocalciferol, calcitriol, dihydrotachysterol, and paricalcitol
- Current cancer
- Malabsorption syndromes
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 DPatients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. | Drug | Treatment |
| ControlPatients randomized to the control will receive a placebo | Drug | Control |
Primary outcome
Knee Society Score (KSS), Functional Component (2012) at 3 Weeks Post Operative
Time frame: Assessed at 3 weeks following surgery
The functional component of the 2012 version of the knee society score at 3 weeks following surgery. Range 0-100. Assessed at 3 weeks following surgery, 3 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.
Knee Society Score (KSS) at 6 Weeks Following Surgery
Time frame: Assessed at 6 weeks following surgery reported
The functional component of the 2012 version of the knee society score at 6 weeks following surgery. Range 0-100. Assessed at 6 weeks following surgery, 6 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.
3 secondary outcomes
Timed up and go Test at 3 Weeks Post Surgery
Time frame: Assessed at 3 weeks following surgery
Timed up and go Test Difference From Baseline to 6 Weeks After Surgery
Time frame: value at 6 weeks minus value at baseline
Number of Participants With Complications
Time frame: 6 weeks following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Denis Nam, MD principal investigator
Rush University Medical Center
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 D in people with Knee Osteoarthritis, run by Rush University Medical Center 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 3 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: finished, as of the sponsor's last update on 12 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Knee Society Score (KSS), Functional Component (2012) at 3 Weeks Post Operative (time frame: Assessed at 3 weeks following surgery). The study lists 2 primary outcomes in all. 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 12 Apr 2023.