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The Effectiveness of Vitamin D Supplementation in Patients With End-stage Knee Osteoarthritis

NCT05981534 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-03-27

No results posted yet for this study

Summary

Osteoarthritis (OA) knee is one of the commonest chronic degenerative conditions. It causes disability in elderlies due to pain and stiffness. The prevalence of radiologic knee osteoarthritis increases in proportion to age, reaching an astounding 64.1% for patients who are over 60 years of age. In 2021, there were over 26,000 patients on the Hospital Authority (HA) waiting list for knee total knee replacement (TKR) and with only 4300 TKRs performed, the nominal waiting time for TKR was almost 89 months.

Low vitamin D can adversely affect cartilage thickness and study suggested that low serum vitamin D is associated with increased radiographic knee OA progression. A systematic review concluded that vitamin D supplements can improve pain and function in patients with knee OA.

Vitamin D has long been recognized for its effect on musculoskeletal health and increasing attention has been focused for its effect on muscle function. Vitamin D have a direct effect on muscle hypertrophy by acting on specific vitamin D receptors (VDRs) on myocytes, and sufficient levels of vitamin D in patients have been found to correlate with an increase in the size, number, and strength of muscle fibres. Vitamin D also seems to exert beneficial effects by its interplay with myokines such as myostatin and irisin.

One study also showed that muscle nuclear VDR was increased by 30% and augmented muscle fibre size by 10% in elderly females (mean age of 78 years) taking vitamin D orally at a rate of 100 µg/day (4000 IU/day) for 4 months.

This will be a double-blinded RCT investigating the effect of vitamin D supplements or knee muscle strength, physical function, pain symptoms and, sarcopenia status. The study will be a follow-up study with assessment at baseline, 3- ,6-and 12-months post vitamin D intervention.

Conditions

Interventions

DRUG

Vitamin D

4000IU/day vitamin D supplement will be used for 6 months

DRUG

Placebo

Placebo will be used for 6 months

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Michael Tim-Yun ONG · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-17
Primary Completion
2025-06-30
Completion
2025-11-30

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981534 on ClinicalTrials.gov