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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT04405960
Eligibility Criteria:
Inclusion Criteria:
* Patients with knee pain due to OA who meet clinical and radiological criteria according to Kellgren-Lawrence grade at least 1 month with knee pain of at least 5 measured using the WOMAC pain index
* Body mass index ≤27 kg/m2
* Do not have any systemic inflammatory diseases or other systemic diseases from history taking and physical examination
* Do not have any other OA in other joints according to physical examination
* Did not do any heavy physical activity or strenuous exercise for at least 1 month (last month)
Exclusion Criteria:
* Grade 4 Kellgren-Lawrence
* WOMAC pain score \>15
* Serum 25(OH)D \>125 nmol/L
* Calcium serum \>10.5 mg/dl
* Diagnosed with rheumatoid or psoriatic arthritis, lupus or cancer, heart or kidney disorders, vitamin D hypersensitivity.
* Knee trauma, including injury to the ligament or meniscus before the study
* Consuming drugs that contain Magnesium (Antacids), Digitalis (Digoxin), Barbiturates or other anti-convulsants for a long time, which will interact with Vitamin D
* Currently undergoing vitamin D therapy for the last 30 days
* Use of other supplements intended to have an effect on cartilage such as glucosamine and chondroitin sulphate
* Undergo intra-articular therapy 3 months before the study
* Consume oral corticosteroids
* Senile dementia or other signs and symptoms of memory loss
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT04405960
Study Brief:
Protocol Section:
NCT04405960