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:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT04229368
Eligibility Criteria:
Inclusion Criteria:
* Adult patients ≥18 years of age undergoing elective unilateral primary TJA for osteoarthritis
* Patients with a pre-operative serum 25(OH)D levels ≥10 ng/mL
* Patients who consent to the study
Exclusion Criteria:
* Adult patients ≥18 years of age undergoing elective primary TJA with a pre-operative serum 25(OH)D2,3 level \<10 ng/mL
* Patients undergoing revision surgery
* Patients lacking mental capacity to comply with study procedures
* Patients with serum 25(OH)D levels between 10-29 ng/dL refusing to stop their current Vitamin D and multivitamins supplementations
* Hypercalcemia (total calcium \>10.6 mg/dL or ionized serum calcium \>5.4mg/dL)
* History of nephrolithiasis
* Granulomatous disease
* Dialysis and advanced kidney disease
* Previous infection/septic arthritis
* Inability to swallow Vitamin D3 pills
* Allergy to Vitamin D3 (It is estimated that 1 in 300 individuals may have an allergy with skin manifestations 17)
* Hypocalcemia (\<8.5 mg/dL)
* Chronic kidney disease (eGFR \<60 mL/minute)
* Known hyperparathyroidism
* Known osteoporosis/insufficiency stress fractures (if normal stresses are applied to an abnormal bone)
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04229368
Study Brief:
Protocol Section:
NCT04229368