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Vitamin D3 Supplementation for Rotator Cuff Tears with Vitamin D Deficiency

N/A
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.
Select...
I have a tear in my shoulder tendon.
Select...
I have a rotator cuff tear suitable for arthroscopic repair.

Timeline

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

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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
~65 spots leftby May 2025
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