The effectiveness of vitamin D supplementation in patients with end-stage knee osteoarthritis: Study protocol for a double-blinded, randomized controlled trial

PLoS One. 2024 Oct 21;19(10):e0309610. doi: 10.1371/journal.pone.0309610. eCollection 2024.

Abstract

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. Trial registration: The trial was registered on clinicaltrials.gov (NCT05981534) on 31st July 2023.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Aged
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Muscle Strength* / drug effects
  • Osteoarthritis, Knee* / drug therapy
  • Sarcopenia / drug therapy
  • Sarcopenia / prevention & control
  • Treatment Outcome
  • Vitamin D Deficiency / complications
  • Vitamin D Deficiency / drug therapy
  • Vitamin D* / administration & dosage
  • Vitamin D* / therapeutic use

Substances

  • Vitamin D

Associated data

  • ClinicalTrials.gov/NCT05981534

Grants and funding

The author(s) received no specific funding for this work.