CClinicalTrials.gg
Not yet recruitingNCT06747559Updated Dec 24, 2024

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

An interventional study of Vitamin D in Osteoarthritis of the Hip or Knee and Joint Arthroplasty, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis of the Hip or Knee
  • Joint Arthroplasty
03

In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's planned enrollment of 300 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Vitamin D oral supplement

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

    Drug: Vitamin D

  • No intervention
    No vitamin D supplementation

Interventions

  • DrugVitamin D

    Vitamin D oral supplementation

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. Muscle strength

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

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

07

Study locations

1 site
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang, China
08

References and documents

Individual participant data

Plan to share: No — IPD cannot be shared publicly due to the sponsor policy.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06747559
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Yiwu Fuyuan Private Hospital, Hangzhou Xiaoshan Traditional Chinese Orthopedic Hospital
Responsible party
Sponsor
First posted
Dec 24, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 24, 2024

Study contacts

Xiang Zhao, MD
Contact
flyingzhao@zju.edu.cn
8613750835297
Zihao Qu, MD
Contact
qu_z.h@zju.edu.cn
8615700079560
Xiang Zhao, MD
principal investigator · 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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