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Vitamin D3 Supplementation for Rotator Cuff Tears with Vitamin D Deficiency

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Waitlist Available

Led By Michael Bogard, DO

Research Sponsored by Community Memorial Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Small to medium sized rotator cuff tear

Acute or chronic rotator cuff tear

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post op

Awards & highlights

Study Summary

This trial is testing whether or not supplementing Vitamin D3 can have positive effects for those who are Vitamin D deficient and have had a shoulder rotator cuff repair.

Who is the study for?

This trial is for people with small to medium rotator cuff tears and Vitamin D deficiency (levels below 30 ng/mL) who can undergo arthroscopic repair surgery. It's not for those with massive, inoperable tears, high calcium levels, bone metabolism disorders, pregnancy plans within two years, or current multivitamin users unwilling to stop.Check my eligibility

What is being tested?

The study tests if taking Vitamin D3 supplements after rotator cuff repair surgery leads to better healing and outcomes compared to a placebo. The idea is that normal Vitamin D levels might help the body heal tendons more effectively.See study design

What are the potential side effects?

Vitamin D3 supplementation may cause side effects like elevated blood calcium levels which could lead to kidney stones or digestive issues. However, these are generally rare when taken as directed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a small to medium tear in my shoulder's rotator cuff.

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I have a tear in my shoulder tendon.

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I have a rotator cuff tear suitable for arthroscopic repair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

American Shoulder and Elbow Surgeon score

Constant-Murray Shoulder Score

SF-12 (12-item Short Form Survey)

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Vitamin D3 supplementation groupActive Control1 Intervention

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

Group II: Placebo groupPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Community Memorial Health SystemLead Sponsor

2 Previous Clinical Trials

520 Total Patients Enrolled

Michael Bogard, DOPrincipal InvestigatorCommunity Memorial Health System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I possibly qualify for enrollment in this experiment?

"This research is seeking 240 individuals with a vitamin d deficit who are aged 18 to 65. The most important requirements for participation include: possessing small or medium sized rotator cuff tears and being eligible for arthroscopic RCR treatment (either single or double row techniques)."

Answered by AI

Does this experiment include participants older than 30?

"As outlined in the criteria for inclusion, only individuals aged 18-65 may enroll in this trial. However, there are 23 studies available to those under 18 and 120 studies open to people over 65 years of age."

Answered by AI

Is this experiment currently accepting participants?

"The clinical trial's last update, which was on August 16th 2021, indicates that it is no longer actively seeking patients. Despite this, there are still 150 other medical trials currently enrolling participants."

Answered by AI

Recent research and studies

The American Journal of Sports MedicineJournal

Effect of Diet-induced Vitamin D Deficiency on Rotator Cuff Healing in a Rat Model

Angeline, Michael E., Richard Ma, Cecilia Pascual-Garrido, Clifford Voigt, Xiang Hua Deng, Russell F. Warren, and Scott A. Rodeo. 2013. “Effect of Diet-induced Vitamin D Deficiency on Rotator Cuff Healing in a Rat Model”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546513505421.

The Journal of Bone and Joint Surgery. British volumeJournal

The Level of Vitamin D in the Serum Correlates with Fatty Degeneration of the Muscles of the Rotator Cuff

Oh, J. H., S. H. Kim, J. H. Kim, Y. H. Shin, J. P. Yoon, and C. H. Oh. 2009. “The Level of Vitamin D in the Serum Correlates with Fatty Degeneration of the Muscles of the Rotator Cuff”. The Journal of Bone and Joint Surgery. British Volume. British Editorial Society of Bone & Joint Surgery. doi:10.1302/0301-620x.91b12.22481.

The American Journal of Sports MedicineJournal

Low Serum Vitamin D Is Not Correlated with the Severity of a Rotator Cuff Tear or Retear After Arthroscopic Repair

Ryu, Keun Jung, Bang Hyun Kim, Yohan Lee, Jinmyoung Dan, and Jae Hwa Kim. 2015. “Low Serum Vitamin D Is Not Correlated with the Severity of a Rotator Cuff Tear or Retear After Arthroscopic Repair”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546515578101.

JAAOS: Global Research and ReviewsJournal