Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT04177758
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) \< 30 mL/minute or creatinine \>1.3 mg/dL
* History of hypercalcemia defined as albumin-corrected hypercalcemia \>12 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04177758
Study Brief:
Protocol Section:
NCT04177758