Osteoarthritis, KneePhase 3NCT04405960
Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients
A Phase 3 study testing Alfacalcidol 1 MCG Oral Capsule and Sugar pill in people with Osteoarthritis, Knee and Aged, run by Syarif Hidayatullah State Islamic University Jakarta at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Aged
- What is being tested?
- Alfacalcidol 1 MCG Oral Capsule and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2017to 31 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Public Health Service Clinic Reni Jaya
South Tangerang, Banten, 15417
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Aged
- Being tested
- Alfacalcidol 1 MCG Oral Capsule, Sugar pill
- Keywords
- Vitamin D, Alfacalcidol, Knee osteoarthritis pain, Cartilage Oligomeric Matrix Protein
- Medical subject headings
- Osteoarthritis, Knee, Pseudoachondroplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfacalcidol 1 MCG Oral CapsuleDrug
Also called Bon-One, One-Alpha
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.
Sugar pillDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Individuals in intervention group were given oral Vitamin D supplements (Alphacalcidol 1 µg) once daily Receives: Drug: Alfacalcidol 1 MCG Oral Capsule |
| Control Group | Placebo comparator | Individuals in control group were given placebo once daily Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Initial and final week (week 0 and 12).
Secondary outcomes (6)
Serum 25(OH)D Concentration Difference
Serum 25(OH)D Concentration as vitamin D deficiency status
Measured: Initial and final week (week 0 and 12).
Body Mass Index
Body mass index, calculated by measuring subject's height and weight
Measured: Once, on week-0
Kellgren-Lawrence Knee OA Grade
Radiological knee OA grading system
Measured: Once, on week-0
Mean Physical Activity
Physical activities performed by subjects using their energy related to work and daily leisure time. Measured using Basic Health Research (Riskesdas) 2007 Questionnaire
Measured: Every 2 weeks (from week-0 until week-12)
Mean Sun Exposure Frequency
Ultraviolet B (UVB) exposure between 7-11 am for ≥ 30 minutes with exposure at least to the face and palms
Measured: Every 2 weeks (from week-0 until week-12)
Mean Vitamin D Consumption
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.
Measured: Every 4 weeks (from week-0 until week-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jul 2017
- Primary completion30 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syarif Hidayatullah State Islamic University Jakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achmad Zaki, Syarif Hidayatullah State Islamic University Jakarta
- Investigators
- Achmad Zaki, PhD, Principal investigator, Faculty of Medicine Syarif Hidayatullah State Islamic University Jakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405960
- Sponsor's protocol ID
- 162/UN2.F10/PPM.00.02/2016
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Author's informed consent does not include IPD sharing agreement.
Publications
Gueli N, Verrusio W, Linguanti A, Di Maio F, Martinez A, Marigliano B, Cacciafesta M. Vitamin D: drug of the future. A new therapeutic approach. Arch Gerontol Geriatr. 2012 Jan-Feb;54(1):222-7. doi: 10.1016/j.archger.2011.03.001. Epub 2011 Apr 1.
PubMed 21458871Bassiouni H, Aly H, Zaky K, Abaza N, Bardin T. Probing The Relation Between Vitamin D Deficiency and Progression of Medial Femoro-tibial Osteoarthitis of the Knee. Curr Rheumatol Rev. 2017;13(1):65-71. doi: 10.2174/1573397112666160404124532.
PubMed 27041085Veronese N, Maggi S, Noale M, De Rui M, Bolzetta F, Zambon S, Corti MC, Sartori L, Musacchio E, Baggio G, Perissinotto E, Crepaldi G, Manzato E, Sergi G. Serum 25-Hydroxyvitamin D and Osteoarthritis in Older People: The Progetto Veneto Anziani Study. Rejuvenation Res. 2015 Dec;18(6):543-53. doi: 10.1089/rej.2015.1671. Epub 2015 Nov 5.
PubMed 26540555Jansen JA, Haddad FS. High prevalence of vitamin D deficiency in elderly patients with advanced osteoarthritis scheduled for total knee replacement associated with poorer preoperative functional state. Ann R Coll Surg Engl. 2013 Nov;95(8):569-72. doi: 10.1308/rcsann.2013.95.8.569.
PubMed 24165338Oemardi M, Horowitz M, Wishart JM, Morris HA, Need AG, O'loughlin PD, Nordin BE. The effect of menopause on bone mineral density and bone-related biochemical variables in Indonesian women. Clin Endocrinol (Oxf). 2007 Jul;67(1):93-100. doi: 10.1111/j.1365-2265.2007.02844.x. Epub 2007 May 9.
PubMed 17490404Ebeling PR, Adler RA, Jones G, Liberman UA, Mazziotti G, Minisola S, Munns CF, Napoli N, Pittas AG, Giustina A, Bilezikian JP, Rizzoli R. MANAGEMENT OF ENDOCRINE DISEASE: Therapeutics of Vitamin D. Eur J Endocrinol. 2018 Oct 12;179(5):R239-R259. doi: 10.1530/EJE-18-0151.
PubMed 30131372Palmer SC, McGregor DO, Craig JC, Elder G, Macaskill P, Strippoli GF. Vitamin D compounds for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005633. doi: 10.1002/14651858.CD005633.pub2.
PubMed 19821349Bartels EM, Christensen R, Christensen P, Henriksen M, Bennett A, Gudbergsen H, Boesen M, Bliddal H. Effect of a 16 weeks weight loss program on osteoarthritis biomarkers in obese patients with knee osteoarthritis: a prospective cohort study. Osteoarthritis Cartilage. 2014 Nov;22(11):1817-25. doi: 10.1016/j.joca.2014.07.027. Epub 2014 Aug 12.
PubMed 25106676Verma P, Dalal K. Serum cartilage oligomeric matrix protein (COMP) in knee osteoarthritis: a novel diagnostic and prognostic biomarker. J Orthop Res. 2013 Jul;31(7):999-1006. doi: 10.1002/jor.22324. Epub 2013 Feb 19.
PubMed 23423905Dirks NF, Ackermans MT, Lips P, de Jongh RT, Vervloet MG, de Jonge R, Heijboer AC. The When, What & How of Measuring Vitamin D Metabolism in Clinical Medicine. Nutrients. 2018 Apr 13;10(4):482. doi: 10.3390/nu10040482.
PubMed 29652819Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol. 2009 Feb;19(2):73-8. doi: 10.1016/j.annepidem.2007.12.001. Epub 2008 Mar 10.
PubMed 18329892Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.
PubMed 16529140Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.
PubMed 21118827KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
PubMed 13498604Guermazi A, Hayashi D, Roemer F, Felson DT, Wang K, Lynch J, Amin S, Torner J, Lewis CE, Nevitt MC. Severe radiographic knee osteoarthritis--does Kellgren and Lawrence grade 4 represent end stage disease?--the MOST study. Osteoarthritis Cartilage. 2015 Sep;23(9):1499-505. doi: 10.1016/j.joca.2015.04.018. Epub 2015 Apr 28.
PubMed 25929973
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04405960
- Acronym / sponsor ID
- 162/UN2.F10/PPM.00.02/2016
- Conditions
- Osteoarthritis, Knee, Aged
- Keywords
- Vitamin D, Alfacalcidol, Knee osteoarthritis pain, Cartilage Oligomeric Matrix Protein
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Syarif Hidayatullah State Islamic University JakartaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Alfacalcidol 1 MCG Oral CapsuleIndividuals in intervention group were given oral Vitamin D supplements (Alphacalcidol 1 µg) once daily |
| Control Group | Placebo comparator | Drug: Sugar pillIndividuals in control group were given placebo once daily |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alfacalcidol 1 MCG Oral CapsuleAlso: Bon-One, One-AlphaThe 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 | Intervention group |
| Sugar pillAlso: PlaceboThe 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. | Drug | Control Group |
Primary outcome
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.
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.
6 secondary outcomes
Serum 25(OH)D Concentration Difference
Time frame: Initial and final week (week 0 and 12).
Body Mass Index
Time frame: Once, on week-0
Kellgren-Lawrence Knee OA Grade
Time frame: Once, on week-0
Mean Physical Activity
Time frame: Every 2 weeks (from week-0 until week-12)
Mean Sun Exposure Frequency
Time frame: Every 2 weeks (from week-0 until week-12)
Mean Vitamin D Consumption
Time frame: Every 4 weeks (from week-0 until week-12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Background: PubMed 21458871Gueli N, Verrusio W, Linguanti A, Di Maio F, Martinez A, Marigliano B, Cacciafesta M. Vitamin D: drug of the future. A new therapeutic approach. Arch Gerontol Geriatr. 2012 Jan-Feb;54(1):222-7. doi: 10.1016/j.archger.2011.03.001. Epub 2011 Apr 1.
- Background: PubMed 27041085Bassiouni H, Aly H, Zaky K, Abaza N, Bardin T. Probing The Relation Between Vitamin D Deficiency and Progression of Medial Femoro-tibial Osteoarthitis of the Knee. Curr Rheumatol Rev. 2017;13(1):65-71. doi: 10.2174/1573397112666160404124532.
- Background: PubMed 26540555Veronese N, Maggi S, Noale M, De Rui M, Bolzetta F, Zambon S, Corti MC, Sartori L, Musacchio E, Baggio G, Perissinotto E, Crepaldi G, Manzato E, Sergi G. Serum 25-Hydroxyvitamin D and Osteoarthritis in Older People: The Progetto Veneto Anziani Study. Rejuvenation Res. 2015 Dec;18(6):543-53. doi: 10.1089/rej.2015.1671. Epub 2015 Nov 5.
- Background: PubMed 24165338Jansen JA, Haddad FS. High prevalence of vitamin D deficiency in elderly patients with advanced osteoarthritis scheduled for total knee replacement associated with poorer preoperative functional state. Ann R Coll Surg Engl. 2013 Nov;95(8):569-72. doi: 10.1308/rcsann.2013.95.8.569.
- Background: PubMed 17490404Oemardi M, Horowitz M, Wishart JM, Morris HA, Need AG, O'loughlin PD, Nordin BE. The effect of menopause on bone mineral density and bone-related biochemical variables in Indonesian women. Clin Endocrinol (Oxf). 2007 Jul;67(1):93-100. doi: 10.1111/j.1365-2265.2007.02844.x. Epub 2007 May 9.
- Background: PubMed 30131372Ebeling PR, Adler RA, Jones G, Liberman UA, Mazziotti G, Minisola S, Munns CF, Napoli N, Pittas AG, Giustina A, Bilezikian JP, Rizzoli R. MANAGEMENT OF ENDOCRINE DISEASE: Therapeutics of Vitamin D. Eur J Endocrinol. 2018 Oct 12;179(5):R239-R259. doi: 10.1530/EJE-18-0151.
- Background: PubMed 19821349Palmer SC, McGregor DO, Craig JC, Elder G, Macaskill P, Strippoli GF. Vitamin D compounds for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005633. doi: 10.1002/14651858.CD005633.pub2.
- Background: PubMed 25106676Bartels EM, Christensen R, Christensen P, Henriksen M, Bennett A, Gudbergsen H, Boesen M, Bliddal H. Effect of a 16 weeks weight loss program on osteoarthritis biomarkers in obese patients with knee osteoarthritis: a prospective cohort study. Osteoarthritis Cartilage. 2014 Nov;22(11):1817-25. doi: 10.1016/j.joca.2014.07.027. Epub 2014 Aug 12.
- Background: PubMed 23423905Verma P, Dalal K. Serum cartilage oligomeric matrix protein (COMP) in knee osteoarthritis: a novel diagnostic and prognostic biomarker. J Orthop Res. 2013 Jul;31(7):999-1006. doi: 10.1002/jor.22324. Epub 2013 Feb 19.
- Background: PubMed 29652819Dirks NF, Ackermans MT, Lips P, de Jongh RT, Vervloet MG, de Jonge R, Heijboer AC. The When, What & How of Measuring Vitamin D Metabolism in Clinical Medicine. Nutrients. 2018 Apr 13;10(4):482. doi: 10.3390/nu10040482.
- Background: PubMed 18329892Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol. 2009 Feb;19(2):73-8. doi: 10.1016/j.annepidem.2007.12.001. Epub 2008 Mar 10.
- Background: PubMed 16529140Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.
- Individual participant dataSharing planned: No. Author's informed consent does not include IPD sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achmad Zaki, PhD principal investigator
Faculty of Medicine Syarif Hidayatullah State Islamic University Jakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alfacalcidol 1 MCG Oral Capsule and Sugar pill in people with Osteoarthritis, Knee and Aged, run by Syarif Hidayatullah State Islamic University Jakarta at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Pain Score Difference (time frame: Initial and final week (week 0 and 12).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04405960, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.