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临床试验/NCT02717897
NCT02717897已完成不适用

Association Between Vitamin D Level and Disease Activity in Ulcerative Colitis

University of Chicago0 个研究点目标入组 248 人开始时间: 2011年11月1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
248
主要终点
25(OH) Vitamin D level (ng/ml)

研究概览

简要总结

The purpose of this study is to test blood and tissue samples of people with Ulcerative Colitis (UC) to see what effects vitamin D may have on the immune system. This research is being done because it could lead to the development of new treatment for people with inflammatory Bowel Disease (IBD).

详细描述

Patients with UC will be recruited and consented prior to colonoscopy or flexible sigmoidoscopy. All patients will be age 18 or older with a known history of UC that has been confirmed by biopsy and an extent of disease of at least 20cm proximal to the anus. Clinical data will be collected on the patient's age, disease duration, family history of IBD, smoking status and history, as well as current medications for IBD through a questionnaire. Data will also be collected regarding current vitamin D supplementation (if taking) and dose. Prior to the endoscopic procedure, peripheral blood will be drawn into two 10ml red top tubes. At the time of endoscopy, five standard size mucosal pinch biopsies will be obtained from 20cm proximal to the anus. . A bar-coded unique identifier label will be applied to each sample. One biopsy will be placed in formalin. Paraffin samples will be maintained at room temperature. Following to the endoscopic procedure, the patient's physician will complete a Mayo score based on the patients current symptoms and endoscopic disease severity. Comparison will be made between disease activity, serum serum 25 hydroxyvitamin D level, and mucosal expression of tight junction proteins as well as proinflammatory cytokines.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

25(OH) Vitamin D level (ng/ml)

时间窗: 1 day

次要结局

  • mucosal IL-8 expression by real time PCR(1 day)
  • mucosal VDR expression by immunohistochemistry(1 day)
  • mucosal claudin-2 by immunohistochemistry(1 day)
  • mucosal zo-1 expression by real time PCR(1 day)
  • mucosal VDR expression by real time PCR(1 day)
  • mucosal zo-1 expression by immunohistochemistry(1 day)
  • Mayo Endoscopy Score(1 day)
  • mucosal occludin expression by real time PCR(1 day)
  • mucosal occludin expression by immunohistochemistry(1 day)
  • mucosal claudin-2 expression by real time PCR(1 day)
  • mucosal TNFa expression by real time PCR(1 day)

研究者

申办方类型
Other
责任方
Sponsor

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Vitamin D and Disease Activity in Ulcerative Colitis | 临床试验