Phase 4
Completed N=137
Evaluating Vitamin D3 Supplement on Post-Op Outcomes
Source: ClinicalTrials.gov NCT04177758 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Knee Society Score (KSS), Functional Component (2012) at 3 Weeks Post Operative — 46.94; 50.89 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Society Score (KSS), Functional Component (2012) at 3 Weeks Post Operative |
46.94; 50.89 | — |
| PRIMARY Knee Society Score (KSS) at 6 Weeks Following Surgery |
55.43; 60.38 | — |
| SECONDARY Timed up and go Test at 3 Weeks Post Surgery |
13.35; 13.46 | — |
| SECONDARY Timed up and go Test Difference From Baseline to 6 Weeks After Surgery |
-0.9; -0.3 | — |
| SECONDARY Number of Participants With Complications |
4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Any patient undergoing primary total knee arthroplasty for osteoarthritis
- Age ≥ 18 years old
- Willingness to undergo randomization and return for all scheduled visits
Exclusion Criteria
- 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) 1.3 mg/dL
- History of hypercalcemia defined as albumin-corrected hypercalcemia >12 mg/dL
Data sourced from ClinicalTrials.gov (NCT04177758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.