Vitamin D to Improve Quadricep Muscle Strength

NCT05174611 | Recruiting Phase 2 DMC

• 1 other identifier: 2020.623
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

ACL Reconstruction; Vitamin D; Quadricep muscle strength; Quadricep muscle atrophy

Outcome Measures

Primary Outcomes (2)

• 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°.

  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).

  Pre operation, 4-, 6- 8- and 12months post operation

Secondary Outcomes (12)

• MRI Muscle thickness

  4- & 8- months post operation

• Ultrasound imaging muscle thickness

  Pre operation, 4-, 6- 8- and 12months post operation

• Passive Knee laxity

  Pre operation, 4-, 6- 8- and 12months post operation

• Change of BMI Anthropometric Measurement

  Pre operation, 4-, 6- 8- and 12months post operation

• Ground reaction force

  pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention

Study Arms (2)

Treatment group

EXPERIMENTAL

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

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.

Other: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

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

Treatment group

Placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-40 with unilateral ACL injury
• Sporting injury with a Tegner score of 7
• Pre-op serum vitamin D level \<20 ng/ml
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 38605374 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Michael Tim-Yun Ong

CONTACT

26364171; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: It is double blinded, subject will receive either the supplement or the placebo with same appearance and package. The lot number of the bottle will be used for randomization. And the investigators will ask the manufactory about it at the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Participants will be assigned into either treatment or placebo groups

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: January 3, 2022
• Study Start: March 17, 2025
• Primary Completion (Estimated): March 17, 2028
• Study Completion (Estimated): September 17, 2029
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)