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Original Investigation |

Effect of Vitamin D Supplementation on Tibial Cartilage Volume and Knee Pain Among Patients With Symptomatic Knee Osteoarthritis A Randomized Clinical Trial

Xingzhong Jin, MD1; Graeme Jones, MD, PhD1; Flavia Cicuttini, MD, PhD2; Anita Wluka, MD, PhD2; Zhaohua Zhu, MD1; Weiyu Han, MD1; Benny Antony, PhD1; Xia Wang, MMSc1; Tania Winzenberg, MD, PhD1,3; Leigh Blizzard, PhD1; Changhai Ding, MD, PhD1,2,4
[+] Author Affiliations
1Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia
2Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
3Faculty of Health, University of Tasmania, Hobart, Tasmania, Australia
4Arthritis Research Institute and Department of Rheumatology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
JAMA. 2016;315(10):1005-1013. doi:10.1001/jama.2016.1961.
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Importance  Observational studies suggest that vitamin D supplementation is associated with benefits for knee osteoarthritis, but current trial evidence is contradictory.

Objective  To compare the effects of vitamin D supplementation vs placebo on knee pain and knee cartilage volume in patients with symptomatic knee osteoarthritis and low vitamin D levels.

Design, Setting, and Participants  A multicenter randomized, double-blind, placebo-controlled clinical trial in Tasmania and Victoria, Australia. Participants with symptomatic knee osteoarthritis and low 25-hydroxyvitamin D (12.5-60 nmol/L) were enrolled from June 2010 to December 2011. The trial was completed in December 2013.

Interventions  Participants were randomly assigned to receive monthly treatment with oral vitamin D3 (50 000 IU; n = 209) or an identical placebo (n = 204) for 2 years.

Main Outcomes and Measures  Primary outcomes were change in tibial cartilage volume (assessed using magnetic resonance imaging [MRI]) and change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score (0 [no pain] to 500 [worst pain]) from baseline to month 24. Secondary outcomes were cartilage defects and bone marrow lesions (assessed using MRI).

Results  Of 413 enrolled participants (mean age, 63.2 years; 50% women), 340 (82.3%) completed the study. The level of 25-hydroxyvitamin D increased more in the vitamin D group (40.6 nmol/L) than in the placebo group (6.7 nmol/L) (P < .001) over 2 years. There were no significant differences in annual change of tibial cartilage volume (−3.4% in the vitamin D group vs −4.2% in the placebo group [between-group difference, 0.8% {95% CI, −0.2% to 1.8%}]; P = .13) or WOMAC pain score (−49.9 in the vitamin D group vs −35.1 in the placebo group [between-group difference, −14.8 {95% CI, −32.5 to 2.9}]; P = .10). There were no significant differences in change of tibiofemoral cartilage defects (0.3 in the vitamin D group vs 0.5 in the placebo group [between-group difference, −0.2 {95% CI, −0.4 to 0.1}]; P = .21) or change in tibiofemoral bone marrow lesions (−0.1 in the vitamin D group vs 0.3 in the placebo group [between-group difference, −0.5 {95% CI, −0.9 to 0.0}]; P = .06). Adverse events (≥1 per patient) occurred in 56 participants in the vitamin D group and in 37 participants in the placebo group (P = .04).

Conclusions and Relevance  Among patients with symptomatic knee osteoarthritis and low serum 25-hydroxyvitamin D levels, vitamin D supplementation, compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or WOMAC knee pain score over 2 years. These findings do not support the use of vitamin D supplementation for preventing tibial cartilage loss or improving WOMAC knee pain in patients with knee osteoarthritis.

Trial Registration  clinicaltrials.gov Identifier: NCT01176344; anzctr.org.au Identifier: ACTRN12610000495022

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Figure 1.
Flowchart of Participants in the VIDEO Study

MRI indicates magnetic resonance imaging.

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Figure 2.
Comparison Between Vitamin D Group and Placebo Group on Change in Clinical Symptoms: the WOMAC Pain Assessment and the Visual Analog Scale for Pain

Higher scores for the Western Ontario and McMaster University Index (WOMAC) and the visual analog scale indicate more severe symptoms of disease. Vertical bars indicate 95% CIs for the mean scores. P values indicate statistical significance between the 2 groups in score change from baseline to month 24.

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