Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients
Condition: Osteoarthritis, Knee; Aged
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Alfacalcidol 1 MCG Oral Capsule; Sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): The subjects in the intervention group were given 1 µg oral capsule alphacalcidol once daily Subjects in the control group were given placebo once daily with similar capsule shape and color to the capsule given to the intervention group. The process of alphacalcidol and placebo encapsulation were carried out by pharmacists in the pharmacy depot under the supervision of researchers and CRO Equilab. Alphacalcidol and placebo were put into plastic pots containing 30 capsules for every 4 weeks for each subject. The pot had an etiquette written explaining how to consume the drug (after breakfast between 7 - 10 a.m.). The drugs' packaging and code numbering were carried out by CRO Equilab to ensure a double-blind procedure. As a control, each subject was equipped with a monitoring card. Alphacalcidol and placebo were given for 12 weeks without interruption. Monitoring of compliance and side effects was performed by physicians every 2 weeks.; The subjects in the control group were given placebo containing simple sugar oral capsule once daily with similar capsule shape and color to the capsule given to the intervention group. The process of alphacalcidol and placebo encapsulation were carried out by pharmacists in the pharmacy depot under the supervision of researchers and CRO Equilab. Alphacalcidol and placebo were put into plastic pots containing 30 capsules for every 4 weeks for each subject. The pot had an etiquette written explaining how to consume the drug (after breakfast between 7 - 10 a.m.). The drugs' packaging and code numbering were carried out by CRO Equilab to ensure a double-blind procedure. As a control, each subject was equipped with a monitoring card. Alphacalcidol and placebo were given for 12 weeks without interruption. Monitoring of compliance and side effects was performed by physicians every 2 weeks.
Other intervention name(s): Bon-One; One-Alpha; Placebo
Intervention MeSH terms: Alfacalcidol; Hydroxycholecalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind, and placebo-controlled trials. Elderly subjects with symptomatic knee OA visited our clinic in Jakarta were recruited. Medical history taking, physical examinations, knee radiology, blood test for Vitamin D (25(OH)D), calcium, and COMP serum were performed. Subjects were then randomly allocated to either intervention group to be given 1 µg Alphacalcidol or control group to be given placebo in 12 weeks.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Vitamin D; Alfacalcidol; Knee osteoarthritis pain; Cartilage Oligomeric Matrix Protein