Chinese and English versions of consent forms.

<div><p>Osteoarthritis (OA) knee is one of the most common chronic degenerative conditions that imposes clinical and economic burdens on individuals and societies worldwide. Previous studies showed vitamin D levels correlated positively with lean muscle mass and grip strength, implying that vitamin D supplementation may improve muscle health in knee OA subjects. This randomized controlled trial (RCT) aims to compare the effects of vitamin D supplementation on knee muscle strength, physical function, pain, and sarcopenia status in patients with end-stage knee OA. Patients and outcome assessors will be blinded to group allocation. Fifty-six end-stage knee OA patients with vitamin D insufficiency fulfilling our inclusion criteria will be invited to participate in this study. Patients will be randomly assigned to take vitamin D supplementation (4,000 IU capsule daily) or placebo for six months. Measurements will be taken at baseline, three and six-month after the commencement of the vitamin D supplement, and 6-month after the interventional period. The primary outcome includes the isometric quadriceps and hamstring muscle strength measured by a hand-held dynamometer. Secondary outcomes include pain, performance-based and self-reported physical function and sarcopenia status. The success of this study will provide scientific evidence of whether the relatively cheap and well-tolerated vitamin D supplement can improve quadriceps muscle strength, physical function, pain symptoms, and sarcopenia status of this increasingly large population for end-stage knee OA patients. The study has great clinical significance given Hong Kong’s lengthy and growing waiting list for complete knee replacement procedures.</p><p><b>Trial registration:</b> The trial was registered on clinicaltrials.gov (<a href="https://clinicaltrials.gov/study/NCT05981534" target="_blank">NCT05981534</a>) on 31<sup>st</sup> July 2023.</p></div>