RecruitingPhase 2NCT05174611

Vitamin D to Improve Quadricep Muscle Strength

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


Sponsor

Chinese University of Hong Kong

Enrollment

60 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Quadriceps muscle strength is one of the key determinants for patients to fulfill the Return-to-Play (RTP) criteria after an anterior cruciate ligament reconstruction (ACLR), in which the muscle size is directly linked to muscle strength. Quadriceps muscle atrophy is unavoidable after ACLR, but the rehabilitation program should increase quadriceps muscle mass. However, despite good rehabilitation compliance, some patient's progress is sub-par and fail to regain muscle mass. Quadriceps muscle atrophy can persist beyond the completion of the rehabilitation program in almost half the patients and the reason behind this is still unknown. This represents an area that requires significant investigation, as quadriceps muscle atrophy and weakness have been shown to be determinants of poor knee function, decreased performance in sports and increased risk of reinjury. Quadriceps muscle atrophy after ACLR is well documented. This can be due to a decreased ability to regain muscle mass with rehabilitation. Athletes are one of the high-risk groups for vitamin D insufficiencies. Vitamin D deficiency can potentially result in decreased hypertrophy when exercising the muscle, leading to a poorer outcome in rehabilitation. Vitamin D has long been recognized for its effect on musculoskeletal health. It can have a direct effect on muscle hypertrophy by acting on specific vitamin D receptors (VDRs) on myocytes, and sufficient or increased levels of vitamin D in patients have been found to correlate with an increase in the size, number, and strength of muscle fibres. Quadriceps muscle hypertrophy after ACLR is triggered by exercise training, facilitated by diet and a number of intrinsic factors. As the rehabilitation programs and diets are similar in patients with varying extents of quadriceps muscle atrophy, individual responses (intrinsic factors) to exercise training may account for the resulting persistent quadriceps muscle atrophy. In this study, the investigators hypothesize that the deficiency of vitamin D may contribute to persistent quadriceps atrophy and weakness. With a stringent double-blinded randomized-controlled-trial (RCT) research design, our proposal will then address the research questions: 'Does vitamin D supplements improve the vitamin D deficiency status in patients after ACL reconstruction?', and 'Does vitamin D supplements improve quadriceps muscle strength for patients after ACLR?'


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vitamin D supplements can help rebuild quadricep (thigh) muscle strength in young people recovering from ACL (anterior cruciate ligament) knee surgery. Many patients recover well overall but have persistent weakness in the operated leg. This study looks specifically at those with low vitamin D levels as a potential factor behind this weakness. You may be eligible if: - You are aged 18 to 40 years - You have had a unilateral ACL injury from a sporting activity (Tegner score of 7) - Your vitamin D level was below 20 ng/ml before surgery - It has been 4 months since your ACL reconstruction and your vitamin D is still below 20 ng/ml - Your operated leg quad strength is still below 70% of your other leg at the 4-month assessment - Neither knee has a prior injury or surgery You may NOT be eligible if: - You have a fracture, major meniscus injury, or full-thickness cartilage damage requiring altered rehab - There are pre-operative signs of arthritis - You have metal implants that interfere with MRI - You did not use a hamstring graft for your ACL reconstruction - You have not been compliant with your rehab program - You regularly use tanning beds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTVitamin D3

Subjects will receive 112 capsules with 4 bottles, 28 capsules in each bottle.

OTHERPlacebo

Subjects will receive 112 capsules with 4 bottles, 28 capsules in each bottle.


Locations(1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

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NCT05174611


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