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

NCT04405960 | Completed Phase 3 DMC

• 1 other identifier: 162/UN2.F10/PPM.00.02/2016
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Aged

Keywords

Vitamin D; Alfacalcidol; Knee osteoarthritis pain; Cartilage Oligomeric Matrix Protein

Outcome Measures

Primary Outcomes (2)

• WOMAC Pain Score Difference

  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

  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 Outcomes (6)

• Serum 25(OH)D Concentration Difference

  Initial and final week (week 0 and 12).

• Body Mass Index

  Once, on week-0

• Kellgren-Lawrence Knee OA Grade

  Once, on week-0

• Mean Physical Activity

  Every 2 weeks (from week-0 until week-12)

• Mean Sun Exposure Frequency

  Every 2 weeks (from week-0 until week-12)

Study Arms (2)

Intervention group

EXPERIMENTAL

Individuals in intervention group were given oral Vitamin D supplements (Alphacalcidol 1 µg) once daily

Drug: Alfacalcidol 1 MCG Oral Capsule

Control Group

PLACEBO COMPARATOR

Individuals in control group were given placebo once daily

Drug: Sugar pill

Interventions

Alfacalcidol 1 MCG Oral Capsule DRUG

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.

Also known as: Bon-One, One-Alpha

Intervention group

Sugar pill DRUG

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.

Also known as: Placebo

Control Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Syarif Hidayatullah State Islamic University Jakarta: lead

Study Sites (1)

Public Health Service Clinic Reni Jaya

South Tangerang, Banten, 15417, Indonesia

Location

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MeSH Terms

Conditions

Osteoarthritis, Knee; Pseudoachondroplasia

Interventions

alfacalcidol; Sugars

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Achmad Zaki, PhD

  Faculty of Medicine Syarif Hidayatullah State Islamic University Jakarta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study used Contract Research Organization (CRO) Equilab to ensure the quality. In this study, researchers, respondents, interviewers, supplement providers, radiology and laboratory staffs were blinded. The interviewers used a questionnaire that had been prepared previously and was used equally for the intervention and control groups. Knee x-ray examination was performed to determine knee OA severity based on Kellgren-Lawrence grading system. It was carried out using the same method and technique between the intervention and control groups. X-ray examination was carried out at the same hospital's radiology unit and was interpreted blindingly by the same radiologist. Blood examination to measure 25(OH)D and COMP was carried out using the same methods and techniques between the intervention and control groups by staffs from the same certified laboratory.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Orthopedic Surgeon, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 28, 2020
• Study Start: July 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: December 31, 2017
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)