Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery

NCT05009498 | Unknown

• 1 other identifier: VITD3RCR
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

Rotator cuff injuries are the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Rotator cuff repair has long been the mainstay of treatment for symptomatic full-thickness tears and medium to large partial thickness tears that do no improve with nonoperative therapies. Approximately 32% of the US population is Vitamin D deficient. This is important for many health reasons, but specifically, Vitamin D has been found to play a critical role in bone mineralization and fracture healing/prevention. There is emerging data to support Vitamin D's role in regulating the inflammatory response throughout the body, which includes soft tissue (i.e. tendons) healing. The role of Vitamin D in tendon to bone healing has yet to be fully investigated, yet it is reasonable to conclude that normal blood levels of Vitamin D would optimize the setting for healing in rotator cuff repair. The investigators hypothesize that Vitamin D deficient patients undergoing shoulder rotator cuff repair will experience more positive outcomes and decreased complications when supplemented with Vitamin D3, compared to Vitamin D deficient patients who do not receive supplementation. The objective of this study is to demonstrate the positive effect of Vitamin D3 in rotator cuff repair healing and patient reported outcomes in patients who are Vitamin D deficient

Conditions

Vitamin D Deficiency; Rotator Cuff Tears

Keywords

Rotator Cuff repair; Rotator Cuff tears; Vitamin D deficiency; Vitamin D3 supplementation; Shoulder arthroscopy

Outcome Measures

Primary Outcomes (24)

• University of California-Los Angeles Shoulder score

  Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.

  Baseline (Preop)

• Constant-Murray Shoulder Score

  Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).

  Baseline (Preop)

• American Shoulder and Elbow Surgeon score

  Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.

  Baseline (Preop)

• SF-12 (12-item Short Form Survey)

  A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average

  Baseline (Preop)

• University of California-Los Angeles Shoulder score

  Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.

  6 weeks post op

• Constant-Murray Shoulder Score

  Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).

  6 weeks post op

• American Shoulder and Elbow Surgeon score

  Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.

  6 weeks post op

• SF-12 (12-item Short Form Survey)

  A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average

  6 weeks post op

• University of California-Los Angeles Shoulder score

  Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.

  12 weeks post op

• Constant-Murray Shoulder Score

  Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).

  12 weeks post op

• American Shoulder and Elbow Surgeon score

  Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.

  12 weeks post op

• SF-12 (12-item Short Form Survey)

  A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average

  12 weeks post op

• University of California-Los Angeles Shoulder score

  Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.

  6 months post op

• Constant-Murray Shoulder Score

  Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).

  6 months post op

• American Shoulder and Elbow Surgeon score

  Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.

  6 months post op

• SF-12 (12-item Short Form Survey)

  A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average

  6 months post op

• University of California-Los Angeles Shoulder score

  Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.

  12 months post op

• Constant-Murray Shoulder Score

  Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).

  12 months post op

• American Shoulder and Elbow Surgeon score

  Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.

  12 months post op

• SF-12 (12-item Short Form Survey)

  A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average

  12 months post op

• University of California-Los Angeles Shoulder score

  Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.

  24 months post op

• Constant-Murray Shoulder Score

  Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).

  24 months post op

• American Shoulder and Elbow Surgeon score

  Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.

  24 months post op

• SF-12 (12-item Short Form Survey)

  A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average

  24 months post op

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Patient will receive a placebo dosing, identical in appearance and at the same intervals as the interventional dose

Other: Placebo

Vitamin D3 supplementation group

ACTIVE COMPARATOR

Patient will receive high-dose Vitamin D3 supplementation in capsule form, identical in appearance and at the same intervals as the placebo dose

Dietary Supplement: Vitamin D3 supplementation

Interventions

Vitamin D3 supplementation DIETARY_SUPPLEMENT

Vitamin D3 in 50,000 IU capsules Loading dose of 150,000 IUs (3 capsules) Interval dosing of 50,000 IUs (1 capsule) every 2 weeks for 1 year

Vitamin D3 supplementation group

Placebo OTHER

Placebo capsule, identical in appearance to the Vitamin D3 supplement capsule Dosing intervals identical in duration and quantity as Vitamin D3 supplement group

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute or chronic rotator cuff tear
• Small to medium sized rotator cuff tear
• Rotator cuff tear which can be treated with arthroscopic RCR (single or double row technique)
• Serum 25(OH)D levels \< 30 ng/mL

You may not qualify if:

• Massive rotator cuff tear that is inoperable or requires superior capsular reconstruction (SCR)
• Revision RCR
• Serum 25(OH)D levels ≥ 30 ng/mL
• Elevated serum calcium (\> 10.5 mg/dL)
• Known or likely undiagnosed disorders of bone metabolism (i.e. Pagets, ostemalacia, osteopetrosis, OI, etc.)
• History of hyperhomocysteinemia
• Vitamin D allergy or other contraindication to Vitamin D supplementation
• Patients currently taking OTC multivitamin that contains Vitamin and unwilling/unable to discontinue use for the duration of this study
• Patient who are pregnant or plan to become pregnant in the next two years
• In the judgment of the investigators, patients who will have trouble adhering to the study follow-up schedule or dosing schedule

Sponsors & Collaborators

• Community Memorial Health System: lead

Study Sites (2)

Community Memorial Health System

Ventura, California, 93003, United States

Location

Ventura County Medical Center

Ventura, California, 93003, United States

Location

Related Publications (10)

• Angeline ME, Ma R, Pascual-Garrido C, Voigt C, Deng XH, Warren RF, Rodeo SA. Effect of diet-induced vitamin D deficiency on rotator cuff healing in a rat model. Am J Sports Med. 2014 Jan;42(1):27-34. doi: 10.1177/0363546513505421. Epub 2013 Oct 16.

  PMID: 24131579 BACKGROUND

• Oh JH, Kim SH, Kim JH, Shin YH, Yoon JP, Oh CH. The level of vitamin D in the serum correlates with fatty degeneration of the muscles of the rotator cuff. J Bone Joint Surg Br. 2009 Dec;91(12):1587-93. doi: 10.1302/0301-620X.91B12.22481.

  PMID: 19949122 BACKGROUND

• Ryu KJ, Kim BH, Lee Y, Dan J, Kim JH. Low Serum Vitamin D Is Not Correlated With the Severity of a Rotator Cuff Tear or Retear After Arthroscopic Repair. Am J Sports Med. 2015 Jul;43(7):1743-50. doi: 10.1177/0363546515578101. Epub 2015 Apr 13.

  PMID: 25868637 BACKGROUND

• Harada GK, Arshi A, Fretes N, Formanek B, Gamradt S, McAllister DR, Petrigliano FA. Preoperative Vitamin D Deficiency Is Associated With Higher Postoperative Complications in Arthroscopic Rotator Cuff Repair. J Am Acad Orthop Surg Glob Res Rev. 2019 Jul 3;3(7):e075. doi: 10.5435/JAAOSGlobal-D-19-00075. eCollection 2019 Jul.

  PMID: 31579883 BACKGROUND

• Dougherty KA, Dilisio MF, Agrawal DK. Vitamin D and the immunomodulation of rotator cuff injury. J Inflamm Res. 2016 Jun 14;9:123-31. doi: 10.2147/JIR.S106206. eCollection 2016.

  PMID: 27366101 BACKGROUND

• Maman E, Somjen D, Maman E, Katzburg S, Sharfman ZT, Stern N, Dolkart O. The response of cells derived from the supraspinatus tendon to estrogen and calciotropic hormone stimulations: in vitro study. Connect Tissue Res. 2016;57(2):124-30. doi: 10.3109/03008207.2015.1114615. Epub 2015 Dec 8.

  PMID: 26646255 BACKGROUND

• Kearns MD, Alvarez JA, Tangpricha V. Large, single-dose, oral vitamin D supplementation in adult populations: a systematic review. Endocr Pract. 2014 Apr;20(4):341-51. doi: 10.4158/EP13265.RA.

  PMID: 24246341 BACKGROUND

• Moon AS, Boudreau S, Mussell E, He JK, Brabston EW, Ponce BA, Momaya AM. Current concepts in vitamin D and orthopaedic surgery. Orthop Traumatol Surg Res. 2019 Apr;105(2):375-382. doi: 10.1016/j.otsr.2018.12.006. Epub 2019 Mar 8.

  PMID: 30858042 BACKGROUND

• Entezari V, Lazarus M. Surgical Considerations in Managing Osteoporosis, Osteopenia, and Vitamin D Deficiency During Arthroscopic Rotator Cuff Repair. Orthop Clin North Am. 2019 Apr;50(2):233-243. doi: 10.1016/j.ocl.2018.10.006.

  PMID: 30850081 BACKGROUND

• Reider B. Big D. Am J Sports Med. 2014 Jan;42(1):25-6. doi: 10.1177/0363546513516922. No abstract available.

  PMID: 24384917 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Michael Bogard, DO

  Community Memorial Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bogard, DO

CONTACT

(714) 465 - 7064; mbogard@cmhshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization at the level of the manufacturer, therefore all patients, investigators, care providers and outcomes assessors with be blinded throughout the duration of the investigation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgery Resident

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 17, 2021
• Study Start: September 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2024
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)