Treatment for Vitamin D Deficiency

Phase-Based Estimates
1
Effectiveness
1
Safety
Ventura County Medical Center, Ventura, CA
+2 More
Eligibility
18+
All Sexes
Eligible conditions
Vitamin D Deficiency

Study Summary

This study is evaluating whether Vitamin D3 supplementation can improve outcomes in patients with rotator cuff injuries.

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Eligible Conditions

  • Vitamin D Deficiency
  • Rotator Cuff Tears
  • Rotator Cuff Injuries

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 4 primary outcomes in patients with Vitamin D Deficiency. Measurement will happen over the course of 24 months post op.

24 months post op
American Shoulder and Elbow Surgeon score
Constant-Murray Shoulder Score
SF-12 (12-item Short Form Survey)
University of California-Los Angeles Shoulder score

Trial Safety

Trial Design

2 Treatment Groups

Placebo group
Placebo group

This trial requires 240 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Placebo group
Other
Patient will receive a placebo dosing, identical in appearance and at the same intervals as the interventional dose
Vitamin D3 supplementation group
DietarySupplement
Patient will receive high-dose Vitamin D3 supplementation in capsule form, identical in appearance and at the same intervals as the placebo dose

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months post op
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months post op for reporting.

Who is running the study

Principal Investigator
M. B.
Michael Bogard, Orthopedic Surgery Resident
Community Memorial Health System

Closest Location

Ventura County Medical Center - Ventura, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

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

Is treatment safe for people?

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The use of a new surgical instrument for use in shoulder surgery is both safe and may be beneficial for patients presenting with these symptoms.

Unverified Answer

What are common treatments for rotator cuff tears?

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Routine repair of rotator cuff tears is often recommended for asymptomatic patients older than 50 years of age. In symptomatic patients, the decision to surgically repair cuff tears depends on a patient's functional status, medical comorbidities, and preference. Surgical repair can improve a patient's function and reduce postoperative pain and stiffness.

Unverified Answer

What is rotator cuff tears?

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Rotator cuff tears can be diagnosed with clinical examinations and imaging studies. However, most clinicians prefer direct examination, history taking and physical examinations of the shoulder to get the most accurate information regarding symptom history, pain, and function. Magnetic resonance imaging can be used for diagnosis when the clinical condition and history of the patient do not allow a certain diagnosis of the lesion. As the rotator cuff tear has a great impact on the shoulder function, appropriate surgical treatments have to be conducted in order to restore an effective functioning of the shoulder joint. Moreover, there is a need for further education of both medical readers as well as general population in order to reduce the prevalence of rotator cuff tears and to detect them earlier.

Unverified Answer

How many people get rotator cuff tears a year in the United States?

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Over 210,000 people in the United States will be diagnosed with a rotator cuff tear each year. Most common are rotator cuff tears due to increased workloads in manual workers' professions (69.8%) and in sales/marketing/management professionals (65.8%); the most common cause of tear are repeated motions in manual work and the use of heavier loads in sales/marketing/management occupations.

Unverified Answer

Can rotator cuff tears be cured?

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Based on these findings from this single-patient case with no post-operative follow-up and no radiologic evidence of rotator cuff healing, the best and/or only conclusion to reach regarding rotator cuff repair after failed primary tendon repair is that the "surgical failure" is not irreparable. It is certainly not. As the cuff heals, the results seem good and encouraging.

Unverified Answer

What are the signs of rotator cuff tears?

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The symptoms most frequently reported regarding shoulder pain were pain while performing a variety of movements. The main finding regarding a change in shoulder motion, regardless of the person's complaint, was a decrease in abduction.

Unverified Answer

What causes rotator cuff tears?

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Rotator cuff tear is commonly treated with arthroscopic repair. Repair of ruptured tendons is the preferred technique, but repair of cuff tears is less successful with partial repair, and surgical repair is preferred when repairs fail.

Unverified Answer

Have there been other clinical trials involving treatment?

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The majority of recent clinical trials involving treatment of rotator cuff tears are not published in peer-reviewed journals. We need to encourage clinical trials to generate scientific data, which can serve as the core of the medical literature, and thereby make the medical community and the lay public aware of the potential benefits and risks of each treatment option.

Unverified Answer

How does treatment work?

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Treatment for rotator cuff tears is often multimodal, combining conventional and minimally invasive surgical techniques. One approach is the surgical repair of the rotator cuff, including arthroscopic repair of partial tears; the other is arthroscopic repair of complete tears, usually without repair at first.

Unverified Answer

What is the latest research for rotator cuff tears?

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As a result of the advances in the understanding of rotator cuff healing and the clinical results, the rate of rotator cuff tears from degeneration or aging has likely increased. There continues to be no strong evidence that exercise is effective for rotator cuff tears. However, the recent studies concerning the efficacy and effectiveness of exercise and physical therapy for degenerative rotator cuff tears are still insufficient. More research is needed.

Unverified Answer

What is the primary cause of rotator cuff tears?

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Routine clinical examination and imaging studies provide sufficient data at the time of diagnosis to determine the primary cause of rotator cuff tears. Routine clinical examination of the shoulder is inadequate to detect and define the primary cause of rotator cuff tears.

Unverified Answer

What is treatment?

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Operative treatment for a rotator cuff cuff tear resulted in improvements in pain and function compared with nonsurgical treatment and were associated with better health-related QoL and satisfaction. In the subgroup of patients who initially underwent arthroscopy with repair, nonsurgical outcomes were similar to those who were treated with arthroscopy and bacitracin/dexamyl. Although the clinical consequences of rotator cuff tears are complex, operative treatment of a rotator cuff tear produces improvements in pain and function, health-related QoL, and satisfaction. There is evidence to support the use of arthroscopy with repair of a degenerative rotator cuff as a surgical treatment and a preferred treatment.

Unverified Answer
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