Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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 Vitamin D (25(OH)D) level has been recognized as a risk factors for knee OA. Cartilage Oligomeric Matrix Protein (COMP) is cartilage degradation product can be used as a diagnostic marker for knee OA. This study aims to determine the effect of Vitamin D supplementation (Alphacalcidol) on pain based on WOMAC indicators and joint cartilage condition based on COMP serum markers in knee OA elderly patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Syarif Hidayatullah State Islamic University Jakarta
• Treatments: Alfacalcidol; Hydroxycholecalciferols

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