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临床试验/NCT04564625
NCT04564625已完成不适用

Relationships Between Vitamin D and Orthopedic Trauma

Methodist Health System2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Vitamin D levels at the time of the index injury through one year post-operative follow up.

研究概览

简要总结

Vitamin D is an essential hormone involved in bone metabolism, bone mineral density maintenance, and bone health. Vitamin D deficiency is putatively linked to poor pediatric orthopedic outcomes [1]. Further, the risk of low vitamin D associated fractures may be greater in minority pediatric populations [2]. In adults, utility of vitamin D alleles as a biomarker for bone density and fracture risk has been debated for over 10 years [3-5]. Peak bone density is achieved at 25 years old; however, most orthopedic trauma patients less than 25 years of age present with substantial vitamin D deficiencies.

详细描述

  1. INTRODUCTION 1.1. Background Vitamin D is an essential hormone involved in bone metabolism, bone mineral density maintenance, and bone health. Vitamin D deficiency is putatively linked to poor pediatric orthopedic outcomes [1]. Further, the risk of low vitamin D associated fractures may be greater in minority pediatric populations [2]. In adults, utility of vitamin D alleles as a biomarker for bone density and fracture risk has been debated for over 10 years [3-5]. Peak bone density is achieved at 25 years old; however, most orthopedic trauma patients less than 25 years of age present with substantial vitamin D deficiencies.

1.2. Aim(s)

  • Identify the prevalence of vitamin D deficiency in young trauma patients with fractures.
  • Describe the merits of vitamin D supplementation in healing and long-term outcomes ≤25 year old trauma patients with fractures.

1.3. Rationale for the study Occurrence of stress and low energy mechanism fractures within a population at peak bone density is troubling and suggestive of underlying pathology. Understanding how to combat vitamin D deficiency, and improve outcomes, is essential in the development of comprehensive and preventative trauma care.

1.4. Hypothesis 1.4.1. Primary Hypothesis Patients aged ≤25yrs old with fractures will have low vitamin-D levels. 2. OBJECTIVES AND STUDY OUTCOME MEASURES 2.1. Study Objectives 2.1.1. Primary Objective Determine the frequency of vitamin D deficiency in fracture patients aged less than 25 years old.

2.1.2. Secondary Objective Report the long-term (one year) outcomes for fracture healing relative to baseline and therapeutic vitamin D levels.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must be >18 years old and ≤25 years old
  • Patients must have any fracture requiring follow-up
  • Patients must have received vitamin-D assessment

排除标准

  • Patients aged >25yrs
  • Prisoners

结局指标

主要结局

Vitamin D levels at the time of the index injury through one year post-operative follow up.

时间窗: February 2016 and February 2020

Vitamin D levels at the time of the index injury through one year post-operative follow up.

次要结局

  • Patient demographics(February 2016 and February 2020)
  • injury characteristics(February 2016 and February 2020)
  • mortality(February 2016 and February 2020)
  • admit information(February 2016 and February 2020)
  • rate of nonunion(February 2016 and February 2020)
  • discharge disposition(February 2016 and February 2020)
  • payer type(February 2016 and February 2020)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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