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

May 22, 2020 updated by: Achmad Zaki, Syarif Hidayatullah State Islamic University Jakarta

Role of Vitamin D (Alphacalcidol) Supplement to Reduce Pain and Cartilage Oligomeric Matrix Protein Serum Levels in Geriatric Knee Osteoarthritis Patients: A Randomized, Double-Blind, Placebo-Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Banten
      • South Tangerang, Banten, Indonesia, 15417
        • Public Health Service Clinic Reni Jaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
Individuals in intervention group were given oral Vitamin D supplements (Alphacalcidol 1 µg) once daily
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.
Other Names:
  • Bon-One
  • One-Alpha
PLACEBO_COMPARATOR: Control Group
Individuals in control group were given placebo once daily
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.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Pain Score Difference
Time Frame: 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.
Initial and final week (week 0 and 12).
Cartilage Oligomeric Matrix Protein Difference
Time Frame: 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.
Initial and final week (week 0 and 12).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum 25(OH)D Concentration Difference
Time Frame: Initial and final week (week 0 and 12).
Serum 25(OH)D Concentration as vitamin D deficiency status
Initial and final week (week 0 and 12).
Body Mass Index
Time Frame: Once, on week-0
Body mass index, calculated by measuring subject's height and weight
Once, on week-0
Kellgren-Lawrence Knee OA Grade
Time Frame: Once, on week-0
Radiological knee OA grading system
Once, on week-0
Mean Physical Activity
Time Frame: 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
Every 2 weeks (from week-0 until week-12)
Mean Sun Exposure Frequency
Time Frame: 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
Every 2 weeks (from week-0 until week-12)
Mean Vitamin D Consumption
Time Frame: 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.
Every 4 weeks (from week-0 until week-12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syarif Hidayatullah State Islamic University Jakarta

Investigators

  • Principal Investigator: Achmad Zaki, PhD, Faculty of Medicine Syarif Hidayatullah State Islamic University Jakarta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

September 30, 2017

Study Completion (ACTUAL)

December 31, 2017

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (ACTUAL)

May 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 162/UN2.F10/PPM.00.02/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Author's informed consent does not include IPD sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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