Abstract
BackgroundOsteoarthritis (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/designRandomised, 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.DiscussionThe 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.Trial registrationClinicalTrials.gov identifier: NCT01176344; Australian New Zealand Clinical Trials Registry: ACTRN12610000495022
Highlights
Osteoarthritis (OA) is a common health issue worldwide in the aging population who are commonly deficient in vitamin D
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, modify disease progression in knee OA
The project manager will visit each site to examine trial procedures to ensure data quality and compliance with the trial protocol. We have proposed this protocol to determine if vitamin D supplementation can slow disease progression in patients with knee OA
Summary
Abbreviations 25-(OH)D: 25-hydroxy-vitamin D; ACR: American College of Rheumatology; AQOL: assessment of quality of life; BIA: bioelectrical impedance analysis; CRF: case report form; FSEL: fast spin echo; FFQ: food frequency questionnaire; GRE: gradient echo; ICC: interclass correlation coefficient; IPAQ: International Physical Activity Questionnaire; LM: lumbar multifidus; MCID: minimal clinically important differences; MMP: metalloproteinase; MRI: magnetic resonance imaging; OA: osteoarthritis; OARSI: Osteoarthritis Research Society International; PHQ-9: Personal Health Questionnaire Depression Scale-9; PGE2: prostaglandin E2; RAAS: renin-angiotensinaldosterone system; RCT: randomized controlled trial; SOP: standard operating procedure; TASOAC: Tasmania Older Adult Cohort; TrAb: transversus abdominus; VAS: visual analogue scales; VIDEO: Vitamin D Effects on Osteoarthritis; VDR: vitamin D receptors; WOMAC: Western Ontario McMaster Universities Osteoarthritis Index.
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