Status:
COMPLETED
Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients
Lead Sponsor:
Syarif Hidayatullah State Islamic University Jakarta
Conditions:
Osteoarthritis, Knee
Aged
Eligibility:
All Genders
60-80 years
Phase:
PHASE3
Brief Summary
Indonesian population's life expectancy has been increasing steadily in the last 3 decades. It potentially increases the prevalence of degenerative diseases, including osteoarthritis (OA). Serum Vitam...
Detailed Description
Vitamin D plays important role to enhance calcium absorption in intestine and promotes mineralization of bones. Several studies found that Vitamin D levels were low in patients with knee OA. Vitamin ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04405960
Start Date
July 1 2017
End Date
December 31 2017
Last Update
May 28 2020
Active Locations (1)
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1
Public Health Service Clinic Reni Jaya
South Tangerang, Banten, Indonesia, 15417