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NCT Number: NCT06747559

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

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

Vitamin D

Drug

Vitamin D oral supplementation

Primary outcomes

  1. Knee joint function

    Time frame: From enrollment to the end of treatment at 1 year

    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.

  2. Hip joint function

    Time frame: From enrollment to the end of treatment at 1 year

    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.

  3. Muscle strength

    Time frame: From enrollment to the end of treatment at 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Zhao, MD

CONTACT

[email protected]

8613750835297

Zihao Qu, MD

CONTACT

[email protected]

8615700079560

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Hangzhou Xiaoshan Traditional Chinese Orthopedic Hospital
  • Yiwu Fuyuan Private Hospital

Registry information

Official study title

Effects of Vitamin D Supplementation on Postoperative Rehabilitation in Hip and Knee Osteoarthritis Patients: a Multicenter Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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