Effects of Vitamin D Supplementation on Postoperative Rehabilitation in Hip and Knee Osteoarthritis Patients

NCT06747559 | Not Yet Recruiting

• 1 other identifier: 2024-1022
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if vitamin D supplementation affects postoperative rehabilitation in osteoarthritis patients who underwent joint arthroplasty. The main questions it aims to answer are: Does oral vitamin D supplementation for a period of time after joint arthroplasty affect the postoperative recovery speed in patients who have vitamin D deficiency? Does oral vitamin D supplementation after joint arthroplasty affect the long-term recovery of joint functions in patients who have vitamin D deficiency? Participants will: Take vitamin D oral supplement every day for 3 months. Visit the clinic in 1, 3, 6, 12 months after joint replacement surgery for checkups and tests.

Conditions

Osteoarthritis of the Hip or Knee; Joint Arthroplasty

Outcome Measures

Primary Outcomes (3)

• Knee joint function

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.

  From enrollment to the end of treatment at 1 year

• Hip joint function

  Harris Hip Score. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

  From enrollment to the end of treatment at 1 year

• Muscle strength

  Using portable muscle strength tester to measure flexor and extensor muscle strength of knee or hip joint

  From enrollment to the end of treatment at 1 year

Study Arms (2)

Vitamin D oral supplement

EXPERIMENTAL

Using vitamin D oral supplement that has been widely used in clinic

Drug: Vitamin D

No vitamin D supplementation

NO INTERVENTION

Interventions

Vitamin D DRUG

Vitamin D oral supplementation

Vitamin D oral supplement

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vitamin D deficiency (blood 25-hydroxyvitamin D value \< 20ng/ml);
• Meeting the diagnostic criteria for hip or knee osteoarthritis;
• Planning to undergo hip or knee arthroplasty after clinical assessment;

You may not qualify if:

• \. Having other diseases that could cause damage to the bone or cartilage structure of the hip or knee, such as trauma, joint infection, congenital joint malformation, and systemic diseases such as rheumatoid arthritis and gout.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Yiwu Fuyuan Private Hospital: collaborator
• Hangzhou Xiaoshan Traditional Chinese Orthopedic Hospital: collaborator

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xiang Zhao, MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Zhao, MD

CONTACT

8613750835297; flyingzhao@zju.edu.cn

Zihao Qu, MD

CONTACT

8615700079560; qu_z.h@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)