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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Vitamin D Deficiency, Rotator Cuff Tears

In brief

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

Key facts

Study ID

NCT05009498

Run by

Community Memorial Health System

People needed

240

Starts

2021-09-01

Expected to finish

2024-08-01

Last updated by the study team

2021-08-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Community Memorial Health System — Ventura, California, United States
• Ventura County Medical Center — Ventura, California, United States

Full record on ClinicalTrials.gov

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