Using Vitamin D to Boost Quadricep Strength After ACL Injury
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
This study is testing if taking Vitamin D3 can help young adults recovering from ACL surgery build stronger thigh muscles.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05174611 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Vitamin D3 supplementation on quadriceps muscle strength in patients recovering from anterior cruciate ligament (ACL) reconstruction. The study focuses on individuals aged 18-40 who have experienced a unilateral ACL injury and have low pre-operative serum vitamin D levels. Participants will be randomly assigned to receive either Vitamin D3 or a placebo, with the aim of determining if Vitamin D can enhance muscle mass and strength during rehabilitation. The trial seeks to address the persistent quadriceps muscle atrophy that affects recovery outcomes and return-to-play criteria.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-40 with a unilateral ACL injury and low serum vitamin D levels who are four months post-surgery.
Not a fit: Patients with significant knee injuries or conditions that require altered rehabilitation, or those who are non-compliant with rehabilitation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved muscle strength and recovery outcomes for patients after ACL reconstruction.
How similar studies have performed: While the specific approach of using Vitamin D for this purpose may be novel, there is existing literature on the importance of vitamin D in muscle health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-40 with unilateral ACL injury 2. Sporting injury with a Tegner score of 7 3. Pre-op serum vitamin D level \<20 ng/ml 4. 4 months post-ACLR with serum Vitamin D level remained \<20ng/ml 5. LSI for quadriceps strength \<70% of contralateral leg at 4-month isokinetic assessment 6. Both knees without history of injury/prior surgery Exclusion Criteria: 1. Concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-operatively 2. Pre-operative radiographic signs of arthritis 3. Metal implants that would cause interference on MRI 4. Non-HS graft for ACLR 5. Patient non-compliant to the rehabilitation program 6. Regular sunbed users
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Michael Tim-Yun Ong
- Email: michael.ong@cuhk.edu.hk
- Phone: 26364171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.