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临床试验/NCT03610932
NCT03610932撤回不适用

Vitamin C Supplementation to Improve EIB in College Student-Athletes

University of Kansas Medical Center2 个研究点 分布在 1 个国家开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in airway inflammatory biomarkers

研究概览

简要总结

The purpose of this research is to assess the association between diet and pulmonary function during standardized EIB testing. Determine the effect of Vitamin C supplementation on airway inflammatory markers and bronchoconstriction after a standardized EIB test compared to usual diet and placebo control.

详细描述

This study will use a double-blind, randomized, cross-over design with subjects serving as their own controls. This study will be conducted over a consecutive five-week period.

All subjects will be asked to discontinue taking their short- and long-acting beta-agonist medication 12 and 24 hours respectively prior to data collection. Also, all subjects will be asked to refrain from caffeine, physical activity, and NSAID use 24 hours prior to testing. In addition all subjects will be asked to abstain from taking any vitamin supplement during the course of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Student or student-athlete who has tested positive for EIB
  • Able to communicate in English

排除标准

  • Forced expiratory volume in 1 second (FEV1) < 70% of predicted, cardiac history,
  • Current respiratory infection
  • > 10 pack year history of smoking
  • Pregnancy.

结局指标

主要结局

Change in airway inflammatory biomarkers

时间窗: Change from Baseline to End of Week 5

Urinary concentrations of cysteine leukotrienes (LTC4-LTE4), prostaglandin (9α,11β-PGF2), and creatinine will be measured.

次要结局

  • Dietary Intake Questionnaire(Change from Baseline to End of Week 5)
  • Pulmonary function testing(Change from Baseline to End of Week 5)
  • Cardiorespiratory Fitness(Baseline)
  • Change in quality of life: asthma quality of life questionnaire (AQLQ)(Change from Baseline to End of Week 5)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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