Vitamin D3 Supplementation vs Placebo for Vitamin D Deficient/Insufficient Patients Undergoing Arthroscopic Rotator Cuff Repair: a Quadruple-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- University of California-Los Angeles Shoulder score
研究概览
简要总结
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
详细描述
Rotator cuff pathology is the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Incidence increases in a direct relationship to age. It is reported that over the age of 60, 28% of patients had full-thickness tears and 26% had partial thickness tears. Increasing age, history of trauma and hand dominance are associated risk factors for rotator cuff tearing. Rotator cuff tears (RCT) can occur from a degenerative process that increases with age, but also associated with micro- or macrotrauma. Rotator cuff repair (RCR) has long been the mainstay treatment for symptomatic full-thickness tears and medium to large partial thickness tears that have failed conservative measures. Long term clinical results for rotator cuff repair exceed 90% good to excellent results at 10 years.
According to the National Center for Health Statistics, approximately 32% of the US population is Vitamin D deficient. It has been widely accepted and studied that Vitamin D (25OHD) plays an important role in bone mineralization and fracture healing/prevention. Also, numerous studies have discovered the association of Vitamin D insufficiency with non-skeletal conditions such as Type 2 diabetes mellitus, cardiovascular disease, chronic pulmonary disease, tuberculosis, and upper respiratory conditions. There is an emerging focus on the role of Vitamin D and soft tissue healing and function.
Vitamin D decreases inflammation in the body by downregulating TNF alpha, which in turn decreases the amount of MMP-9 secreted. Increased MMPs have been associated with poor healing in rotator cuff muscles. Vitamin D levels have also been shown to affect the expression of BMPs, TGF-beta, and RANK.
Vitamin D receptors have been discovered on important soft tissue structures including tendons. It has been posited that Vitamin D's effect on regulating the inflammatory response is associated with tendon healing and overall function.
Traditional oral dosing for Vitamin D is in the Vitamin D3 form. Dosing quantities range from 400 IU to 5000 IU/day. In significantly deficient patients, it is not uncommon to see 50,000 IU/week for several weeks to achieve normal serum Vitamin D levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization at the level of the manufacturer, therefore all patients, investigators, care providers and outcomes assessors with be blinded throughout the duration of the investigation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
University of California-Los Angeles Shoulder score
时间窗: 24 months post op
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
American Shoulder and Elbow Surgeon score
时间窗: 24 months post op
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
Constant-Murray Shoulder Score
时间窗: 24 months post op
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
SF-12 (12-item Short Form Survey)
时间窗: 24 months post op
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
次要结局
未报告次要终点
研究者
Michael Bogard
Orthopedic Surgery Resident
Community Memorial Health System