Evaluating Vitamin D3 Supplement on Post-Op Outcomes
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

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. 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.
    

Intervention name(s): Vitamin D; Control
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Patients randomized to the control will receive a placebo
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment