Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
38 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-05
Study Completion Date
2024-09-30
Brief Summary
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This study evaluates the effects arginine on osteoarthritis (OA) in adults. Participants will be randomly divided into two groups, taking arginine and nothing, respectively. Outcomes will be evaluated by lab test results on OA joint cartilage and self-administered questionnaires. The hypothesis is that arginine can slow down or reverse OA.
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Detailed Description
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1. Patients that meet the inclusion criteria will be approached by a member from their care team, details of this study will be explained. Verbal consent to screening will be obtained during this phone interview and recorded in the clinical trial database; patients will be screened for their eligibility, and a clinical visit will be arranged for eligible patients.
2. Consent form and questionnaires that are commonly used to collect general health information and assess OA patients' mental and physical functions (General Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 36-Item Short Form Health Survey (SF-36)) will be mailed to eligible patients. Patients will read consent form and fill up questionnaires.
3. Eligible patients will be reached by phone by the research assistant at a later date to obtain their verbal consent to further contact regarding participating in the study, and consent status will be recorded in the clinical trial database.
4. Initial clinical visit:
1. All questions and concerns will be answered by researchers, consent form will be signed by participants, research assistant, and one of the investigators, and participants will be given a copy as record.
2. Questionnaires (baseline) will be collected.
3. 6.5 ml of blood sample (baseline) will be collected by a qualified research nurse.
4. Participants will be randomly divided into 2 groups, each group will receive arginine and instruction or nothing, and will take arginine or nothing for 6 months:
* Group I (n=50): 1.5 g of L-arginine daily.
* Group II (n=50): No supplement.
5. Pre-admission clinical vist:
* WOMAC and SF-36 questionnaires (at 6 months of the trial) will be administered.
* 6.5 ml of blood sample (at 6 months of the trial) will be collected.
6. During total joint replacement surgery, small pieces of replaced joint cartilage tissue, which are normally thrown away, will be collected.
7. At 6 and 12 months after the surgery, participants will be reached via phone by the research assistant to complete WOMAC and SF-36 questionnaires. A blood requisition form will be mailed to participants after the last phone interview for their next scheduled routine fasting blood work; 4 ml of blood sample will be collected for the study and sent to the clinical trail lab by the blood collection centre.
8. Lab testing will be conducted; all outcome data will be obtained and analyzed.
2. Consent form and questionnaires that are commonly used to collect general health information and assess OA patients' mental and physical functions (General Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 36-Item Short Form Health Survey (SF-36)) will be mailed to eligible patients. Patients will read consent form and fill up questionnaires.
3. Eligible patients will be reached by phone by the research assistant at a later date to obtain their verbal consent to further contact regarding participating in the study, and consent status will be recorded in the clinical trial database.
4. Initial clinical visit:
1. All questions and concerns will be answered by researchers, consent form will be signed by participants, research assistant, and one of the investigators, and participants will be given a copy as record.
2. Questionnaires (baseline) will be collected.
3. 6.5 ml of blood sample (baseline) will be collected by a qualified research nurse.
4. Participants will be randomly divided into 2 groups, each group will receive arginine and instruction or nothing, and will take arginine or nothing for 6 months:
* Group I (n=50): 1.5 g of L-arginine daily.
* Group II (n=50): No supplement.
5. Pre-admission clinical vist:
* WOMAC and SF-36 questionnaires (at 6 months of the trial) will be administered.
* 6.5 ml of blood sample (at 6 months of the trial) will be collected.
6. During total joint replacement surgery, small pieces of replaced joint cartilage tissue, which are normally thrown away, will be collected.
7. At 6 and 12 months after the surgery, participants will be reached via phone by the research assistant to complete WOMAC and SF-36 questionnaires. A blood requisition form will be mailed to participants after the last phone interview for their next scheduled routine fasting blood work; 4 ml of blood sample will be collected for the study and sent to the clinical trail lab by the blood collection centre.
8. Lab testing will be conducted; all outcome data will be obtained and analyzed.
Conditions
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Knee Osteoarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Arginine
L-arginine 1.5 g capsule by mouth, once daily for 6 months
Group Type
EXPERIMENTAL
L-arginine
Intervention Type
DIETARY_SUPPLEMENT
L-arginine capsule
No Intervention
no supplement for 6 months
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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L-arginine
L-arginine capsule
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* Undergoing total knee replacement surgery in 6 months due to primary knee OA
* Must be ambulatory
* Must live in 50 kilometers perimeter of St. John's, capital city of Newfoundland and Labrador, Canada
* Must be ambulatory
* Must live in 50 kilometers perimeter of St. John's, capital city of Newfoundland and Labrador, Canada
Exclusion Criteria
* Clinical diagnosis of secondary OA or inflammatory arthritis
* Cod liver oil supplementation within 6 months
* Supplementation containing arginine within 6 months
* Osteoporotic fracture, previous knee surgery or arthroscopy within 6 months
* Use of bisphosphonates within 2 years
* Use of Intra-articular viscosupplementation or platelet rich plasma at any point
* Cod liver oil supplementation within 6 months
* Supplementation containing arginine within 6 months
* Osteoporotic fracture, previous knee surgery or arthroscopy within 6 months
* Use of bisphosphonates within 2 years
* Use of Intra-articular viscosupplementation or platelet rich plasma at any point
Minimum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ocean Frontier Institute
UNKNOWN
Sponsor Role
collaborator
Memorial University of Newfoundland
OTHER
Sponsor Role
lead
Responsible Party
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Guangju Zhai, PhD
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Guangju Zhai, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial University of Newfoundland
Locations
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Total Joint Assessment Clinic
St. John's, Newfoundland and Labrador, Canada
Site Status
Countries
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Canada
References
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Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
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BACKGROUND
Sharif B, Kopec J, Bansback N, Rahman MM, Flanagan WM, Wong H, Fines P, Anis A. Projecting the direct cost burden of osteoarthritis in Canada using a microsimulation model. Osteoarthritis Cartilage. 2015 Oct;23(10):1654-63. doi: 10.1016/j.joca.2015.05.029. Epub 2015 Jun 5.
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BACKGROUND
Guermazi A, Roemer FW, Felson DT, Brandt KD. Motion for debate: osteoarthritis clinical trials have not identified efficacious therapies because traditional imaging outcome measures are inadequate. Arthritis Rheum. 2013 Nov;65(11):2748-58. doi: 10.1002/art.38086. No abstract available.
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Grant WB, Schwalfenberg GK, Genuis SJ, Whiting SJ. An estimate of the economic burden and premature deaths due to vitamin D deficiency in Canada. Mol Nutr Food Res. 2010 Aug;54(8):1172-81. doi: 10.1002/mnfr.200900420.
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BACKGROUND
Schwalfenberg G. Not enough vitamin D: health consequences for Canadians. Can Fam Physician. 2007 May;53(5):841-54.
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BACKGROUND
McAlindon TE, Felson DT, Zhang Y, Hannan MT, Aliabadi P, Weissman B, Rush D, Wilson PW, Jacques P. Relation of dietary intake and serum levels of vitamin D to progression of osteoarthritis of the knee among participants in the Framingham Study. Ann Intern Med. 1996 Sep 1;125(5):353-9. doi: 10.7326/0003-4819-125-5-199609010-00001.
Reference Type
BACKGROUND
Bergink AP, Uitterlinden AG, Van Leeuwen JP, Buurman CJ, Hofman A, Verhaar JA, Pols HA. Vitamin D status, bone mineral density, and the development of radiographic osteoarthritis of the knee: The Rotterdam Study. J Clin Rheumatol. 2009 Aug;15(5):230-7. doi: 10.1097/RHU.0b013e3181b08f20.
Reference Type
BACKGROUND
Ding C, Cicuttini F, Parameswaran V, Burgess J, Quinn S, Jones G. Serum levels of vitamin D, sunlight exposure, and knee cartilage loss in older adults: the Tasmanian older adult cohort study. Arthritis Rheum. 2009 May;60(5):1381-9. doi: 10.1002/art.24486.
Reference Type
BACKGROUND
Abu el Maaty MA, Hanafi RS, El Badawy S, Gad MZ. Association of suboptimal 25-hydroxyvitamin D levels with knee osteoarthritis incidence in post-menopausal Egyptian women. Rheumatol Int. 2013 Nov;33(11):2903-7. doi: 10.1007/s00296-012-2551-9. Epub 2012 Nov 4.
Reference Type
BACKGROUND
Heidari B, Heidari P, Hajian-Tilaki K. Association between serum vitamin D deficiency and knee osteoarthritis. Int Orthop. 2011 Nov;35(11):1627-31. doi: 10.1007/s00264-010-1186-2. Epub 2010 Dec 30.
Reference Type
BACKGROUND
Sanghi D, Mishra A, Sharma AC, Singh A, Natu SM, Agarwal S, Srivastava RN. Does vitamin D improve osteoarthritis of the knee: a randomized controlled pilot trial. Clin Orthop Relat Res. 2013 Nov;471(11):3556-62. doi: 10.1007/s11999-013-3201-6. Epub 2013 Aug 1.
Reference Type
BACKGROUND
McAlindon T, LaValley M, Schneider E, Nuite M, Lee JY, Price LL, Lo G, Dawson-Hughes B. Effect of vitamin D supplementation on progression of knee pain and cartilage volume loss in patients with symptomatic osteoarthritis: a randomized controlled trial. JAMA. 2013 Jan 9;309(2):155-62. doi: 10.1001/jama.2012.164487.
Reference Type
BACKGROUND
Arden NK, Cro S, Sheard S, Dore CJ, Bara A, Tebbs SA, Hunter DJ, James S, Cooper C, O'Neill TW, Macgregor A, Birrell F, Keen R. The effect of vitamin D supplementation on knee osteoarthritis, the VIDEO study: a randomised controlled trial. Osteoarthritis Cartilage. 2016 Nov;24(11):1858-1866. doi: 10.1016/j.joca.2016.05.020. Epub 2016 Jun 2.
Reference Type
BACKGROUND
Jin X, Jones G, Cicuttini F, Wluka A, Zhu Z, Han W, Antony B, Wang X, Winzenberg T, Blizzard L, Ding C. Effect of Vitamin D Supplementation on Tibial Cartilage Volume and Knee Pain Among Patients With Symptomatic Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2016 Mar 8;315(10):1005-13. doi: 10.1001/jama.2016.1961.
Reference Type
BACKGROUND
McAlindon TE, Jacques P, Zhang Y, Hannan MT, Aliabadi P, Weissman B, Rush D, Levy D, Felson DT. Do antioxidant micronutrients protect against the development and progression of knee osteoarthritis? Arthritis Rheum. 1996 Apr;39(4):648-56. doi: 10.1002/art.1780390417.
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BACKGROUND
Brand C, Snaddon J, Bailey M, Cicuttini F. Vitamin E is ineffective for symptomatic relief of knee osteoarthritis: a six month double blind, randomised, placebo controlled study. Ann Rheum Dis. 2001 Oct;60(10):946-9. doi: 10.1136/ard.60.10.946.
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BACKGROUND
Wluka AE, Stuckey S, Brand C, Cicuttini FM. Supplementary vitamin E does not affect the loss of cartilage volume in knee osteoarthritis: a 2 year double blind randomized placebo controlled study. J Rheumatol. 2002 Dec;29(12):2585-91.
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BACKGROUND
Morris SM Jr. Recent advances in arginine metabolism: roles and regulation of the arginases. Br J Pharmacol. 2009 Jul;157(6):922-30. doi: 10.1111/j.1476-5381.2009.00278.x. Epub 2009 Jun 5.
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BACKGROUND
Zhang W, Sun G, Likhodii S, Liu M, Aref-Eshghi E, Harper PE, Martin G, Furey A, Green R, Randell E, Rahman P, Zhai G. Metabolomic analysis of human plasma reveals that arginine is depleted in knee osteoarthritis patients. Osteoarthritis Cartilage. 2016 May;24(5):827-34. doi: 10.1016/j.joca.2015.12.004. Epub 2015 Dec 18.
Reference Type
BACKGROUND
Vieth R. Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety. Am J Clin Nutr. 1999 May;69(5):842-56. doi: 10.1093/ajcn/69.5.842.
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BACKGROUND
Vukic M, Neme A, Seuter S, Saksa N, de Mello VD, Nurmi T, Uusitupa M, Tuomainen TP, Virtanen JK, Carlberg C. Relevance of vitamin D receptor target genes for monitoring the vitamin D responsiveness of primary human cells. PLoS One. 2015 Apr 13;10(4):e0124339. doi: 10.1371/journal.pone.0124339. eCollection 2015.
Reference Type
BACKGROUND
Aref-Eshghi E, Liu M, Harper PE, Dore J, Martin G, Furey A, Green R, Rahman P, Zhai G. Overexpression of MMP13 in human osteoarthritic cartilage is associated with the SMAD-independent TGF-beta signalling pathway. Arthritis Res Ther. 2015 Sep 23;17(1):264. doi: 10.1186/s13075-015-0788-x.
Reference Type
BACKGROUND
Pritzker KP, Gay S, Jimenez SA, Ostergaard K, Pelletier JP, Revell PA, Salter D, van den Berg WB. Osteoarthritis cartilage histopathology: grading and staging. Osteoarthritis Cartilage. 2006 Jan;14(1):13-29. doi: 10.1016/j.joca.2005.07.014. Epub 2005 Oct 19.
Reference Type
BACKGROUND
Perez-Portela R, Riesgo A. Optimizing preservation protocols to extract high-quality RNA from different tissues of echinoderms for next-generation sequencing. Mol Ecol Resour. 2013 Sep;13(5):884-9. doi: 10.1111/1755-0998.12122. Epub 2013 May 20.
Reference Type
BACKGROUND
Aref-Eshghi E, Liu M, Razavi-Lopez SB, Hirasawa K, Harper PE, Martin G, Furey A, Green R, Sun G, Rahman P, Zhai G. SMAD3 Is Upregulated in Human Osteoarthritic Cartilage Independent of the Promoter DNA Methylation. J Rheumatol. 2016 Feb;43(2):388-94. doi: 10.3899/jrheum.150609. Epub 2015 Dec 15.
Reference Type
BACKGROUND
Livak KJ, Schmittgen TD. Analysis of relative gene expression data using real-time quantitative PCR and the 2(-Delta Delta C(T)) Method. Methods. 2001 Dec;25(4):402-8. doi: 10.1006/meth.2001.1262.
Reference Type
BACKGROUND
Zhai G, Dore J, Rahman P. TGF-beta signal transduction pathways and osteoarthritis. Rheumatol Int. 2015 Aug;35(8):1283-92. doi: 10.1007/s00296-015-3251-z. Epub 2015 Mar 15.
Reference Type
BACKGROUND
Zhang W, Likhodii S, Aref-Eshghi E, Zhang Y, Harper PE, Randell E, Green R, Martin G, Furey A, Sun G, Rahman P, Zhai G. Relationship between blood plasma and synovial fluid metabolite concentrations in patients with osteoarthritis. J Rheumatol. 2015 May;42(5):859-65. doi: 10.3899/jrheum.141252. Epub 2015 Mar 1.
Reference Type
BACKGROUND
Zhang W, Sun G, Aitken D, Likhodii S, Liu M, Martin G, Furey A, Randell E, Rahman P, Jones G, Zhai G. Lysophosphatidylcholines to phosphatidylcholines ratio predicts advanced knee osteoarthritis. Rheumatology (Oxford). 2016 Sep;55(9):1566-74. doi: 10.1093/rheumatology/kew207. Epub 2016 May 9.
Reference Type
BACKGROUND
Other Identifiers
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20190018
Identifier Type: -
Identifier Source: org_study_id
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