Anterior Cruciate Ligament InjuriesPhase 2NCT05174611
Vitamin D to Improve Quadricep Muscle Strength
A Phase 2 study testing Vitamin D3 in people with Anterior Cruciate Ligament Injuries and Quadriceps Muscle Atrophy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Quadriceps Muscle Atrophy, Anterior Cruciate Ligament Rupture
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Mar 2025to 17 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-40 with unilateral ACL injury
- Sporting injury with a Tegner score of 7
- Pre-op serum vitamin D level <20 ng/ml
- 4 months post-ACLR with serum Vitamin D level remained <20ng/ml
- LSI for quadriceps strength <70% of contralateral leg at 4-month isokinetic assessment
- Both knees without history of injury/prior surgery
Who cannot join
- 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-HS graft for ACLR
- Patient non-compliant to the rehabilitation program
- Regular sunbed users
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Michael Tim-Yun Ong, 26364171, michael.ong@cuhk.edu.hk
About this study
Official title: 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
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
- Being tested
- Vitamin D3, Placebo
- Keywords
- ACL Reconstruction, Vitamin D, Quadricep muscle strength, Quadricep muscle atrophy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Subjects will receive 112 capsules with 4 bottles, 28 capsules in each bottle.
PlaceboOther
Subjects will receive 112 capsules with 4 bottles, 28 capsules in each bottle.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subject in treatment group will receive one capsule of 2000IU Vitamin D3 supplement per day with the duration of 16 weeks. Receives: Dietary Supplement: Vitamin D3 |
| Placebo group | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Isokinetic muscle strength
The dynamometer (Biodex System 4, Biodex Medical Systems Inc., New York, USA) will be used for measuring Isokinetic muscle strength in N. Subjects will perform a standardized warm-up exercise (5 min cycling) followed by the test. Concentric/concentric contractions of knee extension/flexion will be tested at 60°/s and 180°/s. Subjects will be seated on the dynamometer chair with their hips flexed to 85°.
Measured: Pre operation, 4-, 6- 8- and 12months post operation
Change of Biochemical Assays
Blood samples will be taken under non-fasting conditions. Serum / plasma obtained will be immediately stored at -80°C until analysis. Serum 25(OH) Vit-D assay: Serum 25(OH)Vit-D levels will be measured by commercial 25(OH) Vitamin D ELISA kit (Abcam ab213966) according to the manufacturer's instruction, providing the quantitative determination of 25(OH) Vitamin D3 and 25(OH) Vitamin D2. Sensitivity: 1.98 ng/ml (Range: 0.5 ng/ml - 1010 ng/ml).
Measured: Pre operation, 4-, 6- 8- and 12months post operation
Secondary outcomes (12)
MRI Muscle thickness
Muscle volumes of quadricep muscle are measured using a 1.5 or 3.0 Tesla MRI Scanner. Axial (3mm thick cut) T1W images are obtained from the anterior superior iliac supine (ASIS) to patella. Quadriceps muscles were manually outlined in each axial slice. Muscle volume was calculated by summing all of the slice-multiplied by slice thickness. The quality of the muscle is assessed by analyzing the fat content of the muscle mass using technique that has been reported by Reeder et al (6). Bilateral legs will be performed before the start of the vitamin supplementation (4 months post-op) and with the injured side repeated after the completion of the 16-weeks supplementation (8 months postop).The uninjured side will be used as reference for 'normal volume'.
Measured: 4- & 8- months post operation
Ultrasound imaging muscle thickness
The Aixplorer® ultrasound system and a linear transducer probe with a bandwidth of 2-10 MHz were used to measure the muscle thickness of Vastus Medialis (VM), Vastus Lateralis (VL), and Rectus Femoris (RF) on both the injured and uninjured leg. Participants laid supine on a treatment table for the assessment. A measuring tape was used to locate VM, VL, RF and the patella by palpation, consequently marked with a pen for reference. RF was marked at 1/2 of the distance from the anterior superior iliac spine (ASIS) to the superior pole of the patella, VM was located at 1/5 of the distance away from the midpoint of the medial patella border to the ASIS, and VL was noted at 1/3 of the distance from the midpoint of the lateral patella border to the ASIS. After locating the anatomical points, excess contact gel was applied on these points. The transducer probe was aligned in the transverse plane and moved along the entire muscle bundle to capture a view of the VM, VL and RF.
Measured: Pre operation, 4-, 6- 8- and 12months post operation
Passive Knee laxity
To measure anterior-posterior knee laxity, the KT-1000 knee ligament arthrometer (MEDmetric Corp, San Diego, CA, USA) will be used. A manual force test will be applied until a 30lb sound signal is activated. Three trials will be performed. A side difference of 3 mm above is considered clinically relevant.
Measured: Pre operation, 4-, 6- 8- and 12months post operation
Change of BMI Anthropometric Measurement
Body Mass Index (BMI) in kg/m^2 would be calculated by the measured height and weight at 4 months post ACLR before vitamin D supplements, during the eighth week of vitamin D supplements, after the completion of 16 weeks vitamin D supplements, and 12-months post-operation.
Measured: Pre operation, 4-, 6- 8- and 12months post operation
Ground reaction force
The Kinetic variables including vertical and horizontal ground reaction force (GRF) will be evaluated by a synchronized force plate at the centre of the capture volume at 1000Hz.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Knee Joint moments
The kinematics will be assessed by the skin marker-based motion analysis system with the lower-body marker setup followed the OSTRC standard using 16-camera and 16 reflective skin marker during the single leg squat and single leg hop test.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Single leg hop distance
The average of single leg hop distance in cm with three attempts will be measured during the single leg hop test.
Measured: 4weeks, 8 weeks and 8 months after the commencement of intervention
Visual Analogue Scale
The subjective measurement for chronic and acute pain will be recorded by the Visual Analogue Scale (VAS). VAS consists of a 10-cm line which represents the continuum between "painless" and "worst pain from 0 cm to 10 cm. The subject will be asked to draw a mark of it before and after each PEMF treatment session.
Measured: Before and immediate after 1st - 16th of PEMF treatment
Tegner activity score
This is an activity level scaled from 1 (low activity) to 10 (high activity).
Measured: Pre operation, 4-, 6- 8- and 12months post operation
International Knee Documentation Committee
Consists of 10 questions on symptoms and activity ranging from 0 to 100 where 100 implies perfect knee function.
Measured: Pre operation, 4-, 6- 8- and 12months post operation
Lysholm knee scoring system
Consists of eight items, total score ranging from 0 to 100 where higher scores indicate a better outcome with fewer symptoms or disability.
Measured: Pre operation, 4-, 6- 8- and 12months post operation
International Physical Activity Questionnaire
The level of physical activities during the past 7 days will be evaluated with a validated Chinese version of the quantitative physical activity questionnaire.
Measured: Pre operation, 4-, 6- 8- and 12months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start17 Mar 2025
- Primary completion17 Mar 2028 (estimated)
- Study completion17 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned into either treatment or placebo groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174611
- Sponsor's protocol ID
- 2020.623
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2021
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
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.
PubMed 38605374
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05174611
- Acronym / sponsor ID
- 2020.623
- Conditions
- Anterior Cruciate Ligament Injuries, Quadriceps Muscle Atrophy, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Keywords
- ACL Reconstruction, Vitamin D, Quadricep muscle strength, Quadricep muscle atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 17 Mar 2028 (estimated)
- Study completion
- 17 Sep 2029 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?'
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be assigned into either treatment or placebo groups
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Vitamin D3Subject in treatment group will receive one capsule of 2000IU Vitamin D3 supplement per day with the duration of 16 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboSubject 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-40 with unilateral ACL injury
- Sporting injury with a Tegner score of 7
- Pre-op serum vitamin D level <20 ng/ml
- 4 months post-ACLR with serum Vitamin D level remained <20ng/ml
- LSI for quadriceps strength <70% of contralateral leg at 4-month isokinetic assessment
Key exclusion criteria (6 listed)
- 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-HS graft for ACLR
- Patient non-compliant to the rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Subjects will receive 112 capsules with 4 bottles, 28 capsules in each bottle. | Dietary supplement | Treatment group |
| PlaceboSubjects will receive 112 capsules with 4 bottles, 28 capsules in each bottle. | Other | Placebo group |
Primary outcome
Change of Isokinetic muscle strength
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
The dynamometer (Biodex System 4, Biodex Medical Systems Inc., New York, USA) will be used for measuring Isokinetic muscle strength in N. Subjects will perform a standardized warm-up exercise (5 min cycling) followed by the test. Concentric/concentric contractions of knee extension/flexion will be tested at 60°/s and 180°/s. Subjects will be seated on the dynamometer chair with their hips flexed to 85°.
Change of Biochemical Assays
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
Blood samples will be taken under non-fasting conditions. Serum / plasma obtained will be immediately stored at -80°C until analysis. Serum 25(OH) Vit-D assay: Serum 25(OH)Vit-D levels will be measured by commercial 25(OH) Vitamin D ELISA kit (Abcam ab213966) according to the manufacturer's instruction, providing the quantitative determination of 25(OH) Vitamin D3 and 25(OH) Vitamin D2. Sensitivity: 1.98 ng/ml (Range: 0.5 ng/ml - 1010 ng/ml).
12 secondary outcomes
MRI Muscle thickness
Time frame: 4- & 8- months post operation
Ultrasound imaging muscle thickness
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
Passive Knee laxity
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
Change of BMI Anthropometric Measurement
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
Ground reaction force
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Knee Joint moments
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Single leg hop distance
Time frame: 4weeks, 8 weeks and 8 months after the commencement of intervention
Visual Analogue Scale
Time frame: Before and immediate after 1st - 16th of PEMF treatment
Tegner activity score
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
International Knee Documentation Committee
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
Lysholm knee scoring system
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
International Physical Activity Questionnaire
Time frame: Pre operation, 4-, 6- 8- and 12months post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 38605374Ong 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Anterior Cruciate Ligament Injuries and Quadriceps Muscle Atrophy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Tim-Yun Ong (26364171, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Isokinetic muscle strength (time frame: Pre operation, 4-, 6- 8- and 12months post operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05174611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.