Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial

Trials

Volumn 13, Issue , 2012, Pages

  Cao, Yuelong ^a,c   Jones, Graeme ^a   Cicuttini, Flavia ^b   Winzenberg, Tania ^a   Wluka, Anita ^b   Sharman, James ^a   Nguo, Kay ^a   Ding, Changhai ^a,b  

^a UNIVERSITY OF TASMANIA   (Australia)

^b MONASH UNIVERSITY   (Australia)

^c SHUGUANG HOSPITAL AFFILIATED TO SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

Author keywords

Magnetic resonance imaging; Osteoarthritis; Vitamin D

Indexed keywords

PLACEBO; VITAMIN D; BONE DENSITY CONSERVATION AGENT; VITAMIN;

ADULT; AGED; ARTICLE; CLINICAL PROTOCOL; COMPARATIVE STUDY; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; KNEE OSTEOARTHRITIS; KNEE PAIN; MAJOR CLINICAL STUDY; MALE; MUSCLE STRENGTH; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; VITAMIN D DEFICIENCY; VITAMIN SUPPLEMENTATION; WESTERN ONTARIO AND MCMASTER UNIVERSITIES INDEX; ARTHRALGIA; AUSTRALIA; CONTROLLED CLINICAL TRIAL; DRUG EFFECT; METHODOLOGY; PATHOLOGY; TREATMENT OUTCOME;

ARTHRALGIA; BONE DENSITY CONSERVATION AGENTS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; HUMANS; MAGNETIC RESONANCE IMAGING; MUSCLE STRENGTH; OSTEOARTHRITIS, KNEE; PLACEBOS; RESEARCH DESIGN; TASMANIA; TREATMENT OUTCOME; VICTORIA; VITAMIN D; VITAMIN D DEFICIENCY; VITAMINS;

EID: 84864529300     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-131     Document Type: Article

References (55)

1. Felson DT. Clinical practice. Osteoarthritis of the knee. N Engl J Med 2006, 354:8410-8848.
2. Brand C, Hunter D, Hinman R, March L, Osborne R, Bennell K. Improving care for people with osteoarthritis of the hip and knee: how has national policy for osteoarthritis been translated into service models in Australia?. Int J Rheum Dis 2011, 14:181-190. 10.1111/j.1756-185X.2011.01613.x, 21518318.
3. Bjelakovic G, Gluud LL, Nikolova D, Whitfield K, Wetterslev J, Simonetti RG, Bjelakovic M, Gluud C. Vitamin D supplementation for prevention of mortality in adults. Cochrane Database Syst Rev 2011, CD007470.
4. Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol 2009, 19:73-78. 10.1016/j.annepidem.2007.12.001, 2665033, 18329892.
5. Carter GD. Accuracy of 25-hydroxyvitamin D assays: confronting the issues. Curr Drug Targets 2011, 12:19-28. 10.2174/138945011793591608, 20795940.
6. Holick MF. Vitamin D deficiency. N Engl J Med 2007, 357:266-281. 10.1056/NEJMra070553, 17634462.
7. Greene-Finestone LS, Berger C, de Groh M, Hanley DA, Hidiroglou N, Sarafin K, Poliquin S, Krieger J, Richards JB, Goltzman D. 25-Hydroxyvitamin D in Canadian adults: biological, environmental, and behavioral correlates. Osteoporos Int 2011, 22:1389-1399. 10.1007/s00198-010-1362-7, 20730415.
8. van der Mei IA, Ponsonby AL, Dwyer T, Blizzard L, Taylor BV, Kilpatrick T, Butzkueven H, McMichael AJ. Vitamin D levels in people with multiple sclerosis and community controls in Tasmania, Australia. J Neurol 2007, 254:581-590. 10.1007/s00415-006-0315-8, 17426912.
9. Erbas B, Ebeling PR, Couch D, Wark JD. Suburban clustering of vitamin D deficiency in Melbourne, Australia. Asia Pac J Clin Nutr 2008, 17:63-67.
10. van der Mei IA, Ponsonby AL, Engelsen O, Pasco JA, McGrath JJ, Eyles DW, Blizzard L, Dwyer T, Lucas R, Jones G. The high prevalence of vitamin D insufficiency across Australian populations is only partly explained by season and latitude. Environ Health Perspect 2007, 115:1132-1139. 10.1289/ehp.9937, 1940076, 17687438.
11. Tetlow LC, Woolley DE. Expression of vitamin D receptors and matrix metalloproteinases in osteoarthritic cartilage and human articular chondrocytes in vitro. Osteoarthritis Cartilage 2001, 9:423-431. 10.1053/joca.2000.0408, 11467890.
12. McAlindon TE. Nutraceuticals: do they work and when should we use them?. Best Pract Res Clin Rheumatol 2006, 20:99-115. 10.1016/j.berh.2005.09.002, 16483910.
13. Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc 2006, 81:353-373. 10.4065/81.3.353, 16529140.
14. Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr 2006, 84:18-28.
15. 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, 60:1381-1389. 10.1002/art.24486, 19404958.
16. Ding C, Cicuttini F, Jones G. Tibial subchondral bone size and knee cartilage defects: relevance to knee osteoarthritis. Osteoarthritis Cartilage 2007, 15:479-486. 10.1016/j.joca.2007.01.003, 17291789.
17. Laslett L, Ding C, Quinn S, Burgess J, Parameswaran V, Winzenberg T, Jones G. Serum 25 Hydroxy Vitamin D (25OHD) and Incident or Worsening Knee Pain In Older Adults: A Five Year Longitudinal Study [abstract]. Arthritis Rheum 2011, 63(Suppl 10):876.
18. Hodges PW, Richardson CA. Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis. Spine (Phila Pa 1976) 1996, 21:2640-2650.
19. Glerup H, Mikkelsen K, Poulsen L, Hass E, Overbeck S, Andersen H, Charles P, Eriksen EF. Hypovitaminosis D myopathy without biochemical signs of osteomalacic bone involvement. Calcif Tissue Int 2000, 66:419-424. 10.1007/s002230010085, 10821877.
20. Scott D, Blizzard L, Fell J, Ding C, Winzenberg T, Jones G. A prospective study of the associations between 25-hydroxy-vitamin D, sarcopenia progression and physical activity in older adults. Clin Endocrinol (Oxf) 2010, 73:581-587.
21. Hides JA, Richardson CA, Jull GA. Multifidus muscle recovery is not automatic after resolution of acute, first-episode low back pain. Spine (Phila Pa 1976) 1996, 21:2763-2769.
22. Li YC, Kong J, Wei M, Chen ZF, Liu SQ, Cao LP. 1,25-Dihydroxyvitamin D(3) is a negative endocrine regulator of the renin-angiotensin system. J Clin Invest 2002, 110:229-238. 151055, 12122115.
23. Simpson RU, Hershey SH, Nibbelink KA. Characterization of heart size and blood pressure in the vitamin D receptor knockout mouse. J Steroid Biochem Mol Biol 2007, 103:521-524. 10.1016/j.jsbmb.2006.12.098, 1868539, 17275289.
24. Xiang W, Kong J, Chen S, Cao LP, Qiao G, Zheng W, Liu W, Li X, Gardner DG, Li YC. Cardiac hypertrophy in vitamin D receptor knockout mice: role of the systemic and cardiac renin-angiotensin systems. Am J Physiol Endocrinol Metab 2005, 288:E125-E132.
25. Nichols WW, O'Rourke MF. McDonald's blood flow in arteries: Theoretical, experimental and clinical principles 2005, Hodder Arnold, London, 5.
26. Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, et al. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2007, 25:1105-1187. 10.1097/HJH.0b013e3281fc975a, 17563527.
27. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, Howell D, Kaplan D, Koopman W, Longley S, Mankin H, McShane DJ, Medsger T, Meenan RJR, Mikkelsen W, Moskowitz R, Murphy W, Rothschild B, Segal M, Sokoloff L, Wolfe F. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum 1986, 29:1039-1049. 10.1002/art.1780290816, 3741515.
28. Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992, 35:498-502. 10.1002/art.1780350502, 1575785.
29. Altman RD, Hochberg M, Murphy WA, Wolfe F, Lequesne M. Atlas of individual radiographic features in osteoarthritis. Osteoarthritis Cartilage 1995, 3(Suppl A):3-70.
30. Wigg AE, Prest C, Slobodian P, Need AG, Cleland LG. A system for improving vitamin D nutrition in residential care. Med J Aust 2006, 185:195-198.
31. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988, 15:1833-1840.
32. Peterfy CG, Guermazi A, Zaim S, Tirman PF, Miaux Y, White D, Kothari M, Lu Y, Fye K, Zhao S, Genant HK. Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage 2004, 12:177-190. 10.1016/j.joca.2003.11.003, 14972335.
33. Ding C, Martel-Pelletier J, Pelletier JP, Abram F, Raynauld JP, Cicuttini F, Jones G. Meniscal tear as an osteoarthritis risk factor in a largely non-osteoarthritic cohort: a cross-sectional study. J Rheumatol 2007, 34:776-784.
34. Hides J, Gilmore C, Stanton W, Bohlscheid E. Multifidus size and symmetry among chronic LBP and healthy asymptomatic subjects. Man Ther 2008, 13:43-49. 10.1016/j.math.2006.07.017, 17070721.
35. Hides JA, Miokovic T, Belavy DL, Stanton WR, Richardson CA. Ultrasound imaging assessment of abdominal muscle function during drawing-in of the abdominal wall: an intrarater reliability study. J Orthop Sports Phys Ther 2007, 37:480-486.
36. Koppenhaver SL, Hebert JJ, Fritz JM, Parent EC, Teyhen DS, Magel JS. Reliability of rehabilitative ultrasound imaging of the transversus abdominis and lumbar multifidus muscles. Arch Phys Med Rehabil 2009, 90:87-94. 10.1016/j.apmr.2008.06.022, 19154834.
37. Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J 2006, 27:2588-2505. 10.1093/eurheartj/ehl254, 17000623.
38. Aoyagi Y, Shephard RJ. A model to estimate the potential for a physical activity-induced reduction in healthcare costs for the elderly, based on pedometer/accelerometer data from the Nakanojo Study. Sports Med 2011, 41:695-708. 10.2165/11590530-000000000-00000, 21846160.
39. Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003, 35:1381-1395. 10.1249/01.MSS.0000078924.61453.FB, 12900694.
40. Wang Y, Simpson JA, Wluka AE, Teichtahl AJ, English DR, Giles GG, Graves S, Cicuttini FM. Relationship between body adiposity measures and risk of primary knee and hip replacement for osteoarthritis: a prospective cohort study. Arthritis Res Ther 2009, 11:R31. 10.1186/ar2636, 2688176, 19265513.
41. Cohen J. Statistical power analysis for the behavioral sciences 1988, Lawrence Erlbaum Associates, Inc, New Jersey, 2.
42. Wluka AE, Stuckey S, Snaddon J, Cicuttini FM. The determinants of change in tibial cartilage volume in osteoarthritic knees. Arthritis Rheum 2002, 46:2065-2072. 10.1002/art.10460, 12209510.
43. Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA 2005, 293:2257-2264. 10.1001/jama.293.18.2257, 15886381.
44. Wang Y, Wluka AE, Cicuttini FM. The determinants of change in tibial plateau bone area in osteoarthritic knees: a cohort study. Arthritis Res Ther 2005, 7:R687-R693. 10.1186/ar1726, 1174962, 15899054.
45. Wluka AE, Ding C, Jones G, Cicuttini FM. The clinical correlates of articular cartilage defects in symptomatic knee osteoarthritis: a prospective study. Rheumatology (Oxford) 2005, 44:1311-1316.
46. Wang Y, Ding C, Wluka AE, Davis S, Ebeling PR, Jones G, Cicuttini FM. Factors affecting progression of knee cartilage defects in normal subjects over 2 years. Rheumatology (Oxford) 2006, 45:79-84.
47. Losina ECJ, Hunter DJ, Eckstein F, Nevitt MC, Cotofana S, Kwoh CK, Katz JN. The minimal clinically important difference (MCID) in cartilage volume and thickness change in persons with knee osteoarthritis[abstract]. Osteoarthritis Cartilage 2011, 19(Suppl 1):177-178.
48. Henrotin Y, Lambert C, Couchourel D, Ripoll C, Chiotelli E. Nutraceuticals: do they represent a new era in the management of osteoarthritis? - a narrative review from the lessons taken with five products. Osteoarthritis Cartilage 2011, 19:1-21. 10.1016/j.joca.2010.10.017, 21035558.
49. Guermazi A, Hunter DJ, Roemer FW. Plain radiography and magnetic resonance imaging diagnostics in osteoarthritis: validated staging and scoring. J Bone Joint Surg Am 2009, 91(Suppl 1):54-62.
50. Cicuttini FM, Jones G, Forbes A, Wluka AE. Rate of cartilage loss at two years predicts subsequent total knee arthroplasty: a prospective study. Ann Rheum Dis 2004, 63:1124-1127. 10.1136/ard.2004.021253, 1755122, 15115714.
51. Raynauld JP, Martel-Pelletier J, Haraoui B, Choquette D, Dorais M, Wildi LM, Abram F, Pelletier JP. Risk factors predictive of joint replacement in a 2-year multicentre clinical trial in knee osteoarthritis using MRI: results from over 6 years of observation. Ann Rheum Dis 2011, 70:1382-1388. 10.1136/ard.2010.146407, 21551506.
52. Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2011, 96:1911-1930. 10.1210/jc.2011-0385, 21646368.
53. Chel V, Wijnhoven HA, Smit JH, Ooms M, Lips P. Efficacy of different doses and time intervals of oral vitamin D supplementation with or without calcium in elderly nursing home residents. Osteoporos Int 2008, 19:663-671. 10.1007/s00198-007-0465-2, 2277446, 17874029.
54. Hyde J, Stanton WR, Hides JA. Abdominal muscle response to a simulated weight-bearing task by elite Australian Rules football players. Hum Mov Sci 2012, 31:129-138. 10.1016/j.humov.2011.04.005, 21840078.
55. Pilz S, Tomaschitz A, Ritz E, Pieber TR. Vitamin D status and arterial hypertension: a systematic review. Nat Rev Cardiol 2009, 6:621-630. 10.1038/nrcardio.2009.135, 19687790.