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

NCT05009498 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-08-17

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 supplementation

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Community Memorial Health System

    lead OTHER

Principal Investigators

  • Michael Bogard, DO · Community Memorial Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-08-01
Completion
2024-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009498 on ClinicalTrials.gov