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

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.

Conditions

• Osteoarthritis, Knee
• Aged

Interventions

DRUG

Alfacalcidol 1 MCG Oral Capsule

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.

DRUG

Sugar pill

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.

Sponsors & Collaborators

• Syarif Hidayatullah State Islamic University Jakarta

  lead OTHER

Principal Investigators

• Achmad Zaki, PhD · Faculty of Medicine Syarif Hidayatullah State Islamic University Jakarta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2017-09-30

Completion

2017-12-31

Countries

• Indonesia

Study Locations