跳至主要内容
临床试验/NCT03395171
NCT03395171已完成不适用

Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes

Prisma Health-Midlands0 个研究点目标入组 118 人开始时间: 2015年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
118
主要终点
Incidence and prevalence of stress fractures in athlete cohorts

研究概览

简要总结

The main objective of this study is to find a correlation between vitamin D deficiency and stress fracture occurrences in athletes who participate in high-risk activities. These high-risk athletes undergo elevated bone turnover, which requires adequate levels of vitamin D in order to support bone health. It is hypothesized that providing supplemental treatment to athletes showing lower than normal serum vitamin D levels will decrease the occurrence of stress fractures. By recording the dates and specific occurrences of fractures, it may be possible to correlate injury rates with seasons, providing more supportive data to pre-existing literature.

This area of research is lacking in the quantity of prospective studies. Previous studies primarily focus on adolescent, elder, or military recruit populations. While literature has shown that vitamin D plays an important role in bone health, there are no previous studies that directly examine vitamin D deficiency and supplemental treatment in conditioned collegiate athlete populations. This study will add to the existing knowledge and will provide a more specific analysis for athletes.

详细描述

This study will focus on athletes who are at a higher risk of lower extremity stress fractures. Specifically, this study will be looking at male and female athletes on the track, cross-country, soccer, and basketball teams at the University of South Carolina. During the pre-season physical of each student athlete, serum vitamin D levels will be taken and recorded. There will be a certified nurse to draw the blood samples. This will take place at the University of South Carolina Athletic Department and/or the Palmetto Health Lab at 2 Medical Park. Potentially, every athlete of the given teams will be enrolled in the study unless they choose not to. Only subjects showing concentrations below 30 ng/mL, which is indicative of insufficient or deficient levels, will be provided supplemental treatment of 25-(OH) vitamin D. Every enrolled subject will be monitored for injury throughout the season. Any and all injuries will be positively identified, and any confirmed stress fractures will be recorded. Data from prospective seasons will be compared to an incidence percentage of athletes from previous seasons. Previous athletes did not receive any vitamin D treatment. These will be used as a control to determine if treatment affected the occurrence of stress fractures. All physicals and tests will be performed at the University of South Carolina Sports Medicine clinic by the sports medicine staff.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Athlete on one of the following teams at local University: Men/Women Track and Field, Soccer, Basketball, and Women's Cross Country.

排除标准

  • •Athlete currently diagnosed with a stress fracture
  • •Athlete recovering from a lower extremity musculoskeletal injury

研究组 & 干预措施

Prospective Control Group

No Intervention

Athletes with Vitamin D levels higher than 30ng/mL were enrolled and compared but not treated.

Treatment: Cholecalciferol (Vitamin D3)

Experimental

Athletes with Vitamin D levels lower than 30ng/mL will be treated with the supplement for eight weeks.

干预措施: Cholecalciferol (Vitamin D3) (Dietary Supplement)

结局指标

主要结局

Incidence and prevalence of stress fractures in athlete cohorts

时间窗: 5 Years

To compare the incidence and prevalence of student athletes experiencing stress fractures during the 2015-16 academic year with the five previous years of reported data.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验