Vitamin D supplementation for patients with severe knee osteoarthritis
Double-blinded Randomized Controlled Trial Investigating the Effectiveness of Vitamin D Supplementation in Patients With End-stage Knee Osteoarthritis
This study tests if taking vitamin D can help people over 50 with severe knee osteoarthritis feel less pain and move better while they wait for knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05981534 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of vitamin D supplementation in patients suffering from end-stage knee osteoarthritis, particularly those on the waiting list for total knee replacement. It aims to assess whether vitamin D can improve muscle function and reduce pain and stiffness associated with knee osteoarthritis. The study will include patients over 50 years old with vitamin D deficiency and will compare the effects of vitamin D against a placebo. Participants will be monitored for improvements in muscle strength and overall functional outcomes.
Who should consider this trial
Good fit: Ideal candidates are males and females over 50 years old with end-stage knee osteoarthritis who are vitamin D deficient and awaiting total knee replacement.
Not a fit: Patients with connective tissue disorders, recent hip or knee surgeries, or those already taking vitamin D supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option to improve muscle function and alleviate pain in patients with severe knee osteoarthritis.
How similar studies have performed: Previous studies have suggested that vitamin D supplementation can improve pain and function in knee osteoarthritis, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients aged over 50 with end-stage knee OA * Patient are on the waiting list for TKR at Prince of Wales Hospital * Walk unaided for 6 meters * Able to comply with the assessments and has given oral and written consent * Patients with vitamin D insufficiency and deficiency at the baseline measurement (25(OH)D \<30 ng/mL) Exclusion Criteria: * Patients with connective tissue disorders or myositis condition * History of any Hip \& Knee surgery * Patients with malnutrition were assessed by Mini-Nutritional assessment. * Patients with acute immobility (i.e., post-hip fracture or post-acute hospital admission) * Patient scheduled for TKR within six months * Patients already taking vitamin D supplements * Patients with a known contraindication to vitamin D treatment (such as allergy) * Patients who have renal impairment with glomerular filtration rate (eGFR) \< 30 ml/minute
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Michael Tim-Yun ONG — Chinese University of Hong Kong
- Study coordinator: Michael Tim-Yun ONG, MSc
- Email: michael.ong@cuhk.edu.hk
- Phone: 26364171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.