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

NCT05981534 | Recruiting DMC

• 1 other identifier: 2022.252
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Vitamin D Deficiency; Sarcopenia; Knee Osteoarthritis

Keywords

Vitamin D; Sarcopenia; Muscle atrophy; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Quadriceps and hamstring muscle strength assessment

  Hand-held dynamometer microFET2 (Hoggan Scientific, Salt Lake City UT, USA) will be used to assess lower limb strength and power. Assessment of isometric muscle strength and power will be performed with the participants in a seated position to assess knee extensors and knee flexors. All tests will involve maximal voluntary isometric contractions. Both limbs will be assessed to record side-to-side difference. Two trials were recorded for each muscle group.

  Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement

Secondary Outcomes (12)

• The 6-meter timed walking test

  Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement

• 5-time Chair stand test

  Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement

• Dual Energy X-ray Absorptiometry (DXA)

  Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive vitamin D supplement for 6 months

Drug: Vitamin D

Control group

PLACEBO COMPARATOR

The control group will receive placebo for 6 months

Drug: Placebo

Interventions

Vitamin D DRUG

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

Also known as: SODX Co., Ltd, Osaka, Japan

Intervention group

Placebo DRUG

Placebo will be used for 6 months

Also known as: SODX Co., Ltd, Osaka, Japan

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Wang QW, Ong MT, Man GC, Yeung YM, He X, Choi BC, Ng JP, Mok DK, Lam TP, Yung PS. 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.

  PMID: 39432457 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Sarcopenia; Osteoarthritis, Knee; Muscular Atrophy

Interventions

Vitamin D; Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Tim-Yun ONG

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Tim-Yun ONG, MSc

CONTACT

26364171; michael.ong@cuhk.edu.hk

26364171 ONG, MSc

CONTACT

26364171; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: March 17, 2024
• Primary Completion: June 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewer

Locations

HK (1)