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Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial
Cao, Y and Jones, G and Cicuttini, F and Winzenberg, T and Wluka, A and Sharman, J and Nguo, K and Ding, C, Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial, Trials, 13, (131) pp. 1-8. ISSN 1745-6215 (2012) [Contribution to Refereed Journal]
Licensed under Creative Commons Attribution 2.0 Generic (CC BY 2.0) http://creativecommons.org/licenses/by/2.0/
Background: Osteoarthritis (OA) is a common health issue worldwide in the aging population who are also commonly deficient in vitamin D. Our previous study suggested that higher serum 25-(OH)D levels were associated with reduced knee cartilage loss, implying that vitamin D supplementation may prevent the progression of knee OA. The aim of the VItamin D Effects on OA (VIDEO) study is to compare, over a 2- year period, the effects of vitamin D supplementation versus placebo on knee structural changes, knee pain, and lower limb muscle strength in patients with symptomatic knee OA.
Methods/design: Randomised, placebo-controlled, and double-blind clinical trial aiming to recruit 400 subjects (200 from Tasmania and 200 from Victoria) with both symptomatic knee OA and vitamin D deficiency (serum [25-(OH)D] level of > 12.5 nmol/liter and < 60 nmol/liter). Participants will be randomly allocated to vitamin D supplementation (50,000 IU compounded vitamin D3 capsule monthly) or identical inert placebo group for 2 years. The primary endpoint is loss of knee cartilage volume measured by magnetic resonance imaging (MRI) and Western Ontario and McMaster Universities Index of OA (WOMAC) knee pain score. The secondary endpoints will be other knee structural changes, and lower limb muscle strength. Several other outcome measures including core muscle images and central blood pressure will be recorded. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modeling analyses. Both intention to treat and per protocol analyses will be utilized.
Discussion: The trial is designed to test if vitamin D supplementation will reduce loss of knee cartilage volume, prevent the progression of other knee structural abnormalities, reduce knee pain and strengthen lower limb muscle strength, thus modify disease progression in knee OA.
|Item Type:||Contribution to Refereed Journal|
|Keywords:||vitamin D, osteoarthritis, magnetic resonance imaging|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Clinical sciences|
|Research Field:||Rheumatology and arthritis|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Cao, Y (Associate Professor Yue long Cao)|
|UTAS Author:||Jones, G (Professor Graeme Jones)|
|UTAS Author:||Winzenberg, T (Professor Tania Winzenberg)|
|UTAS Author:||Sharman, J (Professor James Sharman)|
|UTAS Author:||Nguo, K (Ms Kay Nguo)|
|UTAS Author:||Ding, C (Professor Chang-Hai Ding)|
|Web of Science® Times Cited:||44|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||356 View Download Statistics|
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