Actively Recruiting

Phase 2
Age: 18Years - 40Years
All Genders
ID05174611

Vitamin D as an Intervention for Improving Quadricep Muscle Strength in Patients After Anterior Cruciate Ligament Reconstruction: A Randomized Double-Blinded, Placebo-Controlled Clinical Trial

Led by Chinese University of Hong Kong · Updated on 2025-03-18

60

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how vitamin D supplements might help improve quadriceps muscle strength in patients recovering from anterior cruciate ligament reconstruction (ACLR). Quadriceps muscle atrophy after ACLR is common and can affect knee function and increase the risk of reinjury. Since vitamin D plays a role in muscle health and athletes often have vitamin D deficiencies, this trial explores whether vitamin D supplements can enhance muscle recovery after ACLR. Participants are randomly assigned to receive either a daily 2000 IU vitamin D3 capsule or a matching placebo capsule for 16 weeks. This is a double-blinded, placebo-controlled trial, meaning neither the participants nor the researchers know who receives vitamin D or placebo during the study period. The study aims to assess the effect of vitamin D supplementation on muscle strength and vitamin D levels post-surgery. During the study, participants will be monitored before surgery and at several time points up to 12 months after ACLR. Muscle strength, biochemical markers, MRI and ultrasound muscle thickness, knee stability, physical activity, and pain levels will be assessed. Researchers will track changes in quadriceps strength and related outcomes to understand vitamin D's impact on muscle recovery and knee function after ACLR.

CONDITIONS

Brief Title

Vitamin D to Improve Quadricep Muscle Strength

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-40 with unilateral ACL injury
  • Sporting injury with a Tegner score of 7
  • Pre-op serum vitamin D level below 20 ng/ml
  • 4 months post-ACLR with serum vitamin D level remained below 20 ng/ml
  • Limb Symmetry Index (LSI) for quadriceps strength less than 70% of contralateral leg at 4-month isokinetic assessment
  • Both knees without history of injury or prior surgery
Not Eligible

You will not qualify if you...

  • Concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-operatively
  • Pre-operative radiographic signs of arthritis
  • Metal implants that would cause interference on MRI
  • Non-hamstring tendon graft for ACL reconstruction
  • Patient non-compliant to the rehabilitation program
  • Regular sunbed users

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 16 weeks

Participants take one capsule daily of either Vitamin D3 or placebo for 16 weeks to improve quadricep muscle strength after ACL reconstruction.

Daily capsule intake with scheduled follow-up assessments

Follow-up

Duration - Up to 12 months post operation

Participants undergo assessments of muscle strength, biochemical assays, imaging, and knee function up to 12 months post operation.

Visits at 4, 6, 8, and 12 months post operation with additional visits at 4 and 8 weeks after intervention start

Trial Site Locations

Total: 1 location

1

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

Loading map...

Research Team

M

Michael Tim-Yun Ong

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Comparison of Outcomes After Anterior Cruciate Ligament (A...

ACL Reconstruction

Actively Recruiting

1 location

ACL Reconstruction With Human Allograft Cortical Bone Screw ...

Anterior Cruciate Ligament Rupture

Actively Recruiting

1 location

Antero-lateral Ligament Reconstruction Versus Modified Lemai...

Anterior Cruciate Ligament Injuries

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Vitamin D as an intervention for improving quadriceps muscle strength in patients after anterior cruciate ligament reconstruction: study protocol for a randomized double-blinded, placebo-controlled clinical trial.

Michael Tim-Yun Ong, Xiaomin Lu, Ben Chi-Yin Choi...

https://pubmed.ncbi.nlm.nih.gov/38605374