Vitamin D to Improve Quadricep Muscle Strength

NCT ID: NCT05174611

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2029-09-17

Brief 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?'

Conditions

Anterior Cruciate Ligament Injuries; Quadriceps Muscle Atrophy; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

Subject in treatment group will receive one capsule of 2000IU Vitamin D3 supplement per day with the duration of 16 weeks.

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

Subject in placebo group will receive one capsule of placebo per day which looks exactly same as the Vitamin D3 capsule with the duration of 16 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Vitamin D3

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Tim-Yun Michael ONG

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Michael Tim-Yun Ong

Role: CONTACT

michael.ong@cuhk.edu.hk

26364171

Facility Contacts

Michael Tim-Yun Ong

Role: primary

michael.ong@cuhk.edu.hk

26364171

References

Ong MT, Lu X, Choi BC, Wan SW, Wang Q, Man GC, Lui PP, Fong DT, Mok DK, Yung PS. 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. Trials. 2024 Apr 11;25(1):251. doi: 10.1186/s13063-024-08094-w.

Reference Type: DERIVED

PMID: 38605374 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2020.623

Identifier Type: -

Identifier Source: org_study_id