Effect of Vitamin D Supplementation on the Rehabilitation of Patients After Rotator Cuff Tear Repair

NCT06984068 | Not Yet Recruiting DMC

• 1 other identifier: 2025.058
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Rotator cuff tears are a significant health concern that severely affect shoulder joint mobility in patients. Common clinical manifestations of RCTs include shoulder pain, limited range of motion, joint instability, muscle weakness, and functional disability. In patients with rotator cuff tears, the prevalence of vitamin D deficiency ranges from 8.3% to 71%. Given its critical role in muscle strength and function, vitamin D is emerging as an important factor in the management of musculoskeletal disorders, including rotator cuff injuries. Despite the promising evidence regarding vitamin D's role in muscle strength and tendon healing, the specific impact of vitamin D supplementation on postoperative rehabilitation remains unclear. Given that vitamin D deficiency is easily diagnosed and treated, it is considered a modifiable risk factor that could be utilized in orthopedic care to improve patient outcomes. Vitamin D supplementation is a cost-effective and potentially efficient intervention that may enhance muscle strength, reduce postoperative pain, and improve joint function in patients recovering from rotator cuff repair. The objective of this study is to investigate the effects of vitamin D supplementation on postoperative outcomes in patients undergoing arthroscopic rotator cuff repair. The study will be conducted as a randomized controlled trial, with participants receiving either a daily dose of 4000 IU of vitamin D or a placebo. The primary outcomes to be evaluated include muscle strength, postoperative pain, and joint function. Blood samples will be collected at baseline, and after 3 months, 6 months, and 12 months of supplementation to monitor the effects of vitamin D on serum levels and its correlation with clinical outcomes.

Conditions

Rotator Cuff Tear

Keywords

rotator cuff tear; rotator cuff tear repair; vitamin D

Outcome Measures

Primary Outcomes (1)

• External and internal rotation isometric strength of the shoulder

  Isometric shoulder strength will be tested using an isokinetic dynamometer (Biodex System 2, Shirley, New York). Following the protocol described by Hughes and colleagues, strength testing will be performed at the following joint positions: coronal-plane abduction (ABD) at 30° of abduction, internal rotation (IR) at 15° of frontal-plane elevation and 0° of humeral rotation, and external rotation (ER) at 15° of frontal-plane elevation and 0° of humeral rotation. To isolate shoulder strength and minimize the likelihood of compensation with other muscle groups, patients will be secured to the Biodex system with 2 hook-and-loop straps diagonally across their torso. Three trials will be performed at each position, with at least 2 minutes of rest between each trial. The average of the 3 trials will be calculated and recorded as the patient's maximum isometric strength. Both shoulders will be tested, and the testing order will be randomized. To account for any inherent differences in strengt

  Baseline, 3 months, 6 months and 12 months post-intervention

Secondary Outcomes (7)

• Visual Analog Scale (VAS)

  Baseline, 3 months, 6 months and 12 months post-intervention

• the American Shoulder and Elbow Surgeons (ASES) score

  Baseline, 3 months, 6 months and 12 months post-intervention

• the University of California, Los Angeles (UCLA) score

  Baseline, 3 months, 6 months and 12 months post-intervention

• the Constant-Murley score

  Baseline, 3 months, 6 months and 12 months post-intervention

• Range of motion (ROM)

  Baseline, 3 months, 6 months and 12 months post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive vitamin D supplement for 6 months

Drug: Vitamin D

Control group

PLACEBO COMPARATOR

The control group will receive placebo for 6 months

Drug: Placebo

Interventions

Vitamin D DRUG

4000IU/day vitamin D supplement will be used for 6 months

Intervention group

Placebo DRUG

Placebo will be used for 6 months

Control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged between 40 and 70 years.
• Clinically and radiologically (magnetic resonance imaging) diagnosed full-thickness supraspinatus tendon tears that were confirmed by arthroscopic surgery and could be surgically repaired.
• Degree of supraspinatus tendon tear according to the DeOrio and Cofield grading system as moderate tear (1-3 cm) and mild tear (\<1 cm).
• Serum vitamin D level \<30 ng/mL \>20 ng/mL before rotator cuff tears surgery
• Signed informed consent and underwent 12-month follow-up.

You may not qualify if:

• Presence of other shoulder pathologies such as subscapularis tear, adhesive capsulitis, long head of biceps tendonitis, calcific tendonitis, or shoulder tumor.
• Large or unrepairable rotator cuff tear (\>3 cm).
• Previous history of shoulder surgery or recurrent rotator cuff tears.
• Combined injury to the shoulder labrum, articular cartilage or biceps tendon.
• Contraindications to vitamin D supplementation (e.g., allergies).
• Serious comorbidities such as cardiovascular disease.
• Severe osteoporosis or rheumatoid arthritis.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Tim-yun Michael Ong

CONTACT

+85226364171; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

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

Locations

HK (1)