Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients
- Conditions
- AgedOsteoarthritis, Knee
- Interventions
- Drug: Sugar pill
- Registration Number
- NCT04405960
- Lead Sponsor
- Syarif Hidayatullah State Islamic University Jakarta
- 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 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.
- 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 D deficiency were found in 50% of women age 45-55 years old and 35% of women age 60-90 years old in Jakarta and Bekasi. Alphacalcidol is a vitamin D supplementation recommended to be used in patients with renal insufficiency, which is prevalent in elderly. Alfacalcidol does not need to undergo renal 1-alpha-hydroxylation which impaired in renal insufficiency, although it can still cause hypercalcemia.
Current detection and diagnosis of knee OA relies on plain radiological examination, which is not really objective because it depends on radiological expertise and experience. Moreover, plain radiological diagnosis has limited ability to detect joint damage at an early stage. Therefore, knee OA is often diagnosed at advanced stage. For this reason, selecting accurate joint cartilage biomarkers is important to detect and predict the severity of OA objectively and at earlier stage. Cartilage Oligomeric Matrix Protein (COMP) is one of degradation products released into synovium fluid and bloodstream from cartilage matrix turnover process. Therefore, COMP can be used as a marker of diagnosis and cartilage injury severity of knee OA.
Currently, there has been no study about the association of Vitamin D supplementation with pain level and cartilage matrix turnover process in Indonesia. Therefore, this study aims to determine the effect of Vitamin D supplementation (Alphacalcidol) on pain and joint cartilage condition in elderly patients with knee OA.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Alfacalcidol 1 MCG Oral Capsule Individuals in intervention group were given oral Vitamin D supplements (Alphacalcidol 1 µg) once daily Control Group Sugar pill Individuals in control group were given placebo once daily
- Primary Outcome Measures
Name Time Method Cartilage Oligomeric Matrix Protein Difference Initial and final week (week 0 and 12). Serum concentration of Cartilage Oligomeric Matrix Protein (COMP) as a biomarker for the severity of knee OA.
WOMAC Pain Score Difference Initial and final week (week 0 and 12). Instrument for assessing pain in knee OA patients from The Western Ontario \& McMaster University OA Index. WOMAC pain score was assessed every 2 weeks to ensure that subject's pain within inclusion criteria.
- Secondary Outcome Measures
Name Time Method Serum 25(OH)D Concentration Difference Initial and final week (week 0 and 12). Serum 25(OH)D Concentration as vitamin D deficiency status
Body Mass Index Once, on week-0 Body mass index, calculated by measuring subject's height and weight
Mean Physical Activity Every 2 weeks (from week-0 until week-12) Physical activities performed by subjects using their energy related to work and daily leisure time. Measured using Basic Health Research (Riskesdas) 2007 Questionnaire
Kellgren-Lawrence Knee OA Grade Once, on week-0 Radiological knee OA grading system
Mean Sun Exposure Frequency Every 2 weeks (from week-0 until week-12) Ultraviolet B (UVB) exposure between 7-11 am for ≥ 30 minutes with exposure at least to the face and palms
Mean Vitamin D Consumption Every 4 weeks (from week-0 until week-12) The amount of Vitamin D consumption by subjects, which is calculated based on the consumption of fruits, vegetables, milk and its processed products, fish, etc.
Trial Locations
- Locations (1)
Public Health Service Clinic Reni Jaya
🇮🇩South Tangerang, Banten, Indonesia