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临床试验/NL-OMON44853
NL-OMON44853已完成4 期

The effect of Vitamin D3 to prevent postoperative relapse of Crohn*s Disease: a placebo-controlled randomized trial (DETECT) - DETECT

Academisch Medisch Centrum0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Age * 18 years, either male or female
  • - Established CD
  • - First or second ileocolonic resection with ileocolonic anastomosis and removal of all tissue macroscopically affected by CD according to the surgeon
  • - Able to give written informed consent
  • - Normal levels of serum calcium at inclusion, corrected for albumin
  • - Being able to resume oral intake within 2 weeks after surgery

排除标准

  • - Patients in whom not all visible CD has been resected
  • - Active fistulizing perianal disease (requiring anti TNF treatment)
  • - Extensive small bowel resection
  • - Third, fourth or later ileocolonic resection
  • - Patients undergoing ileocoecal resection in the Lir!c Trial (NTR 1150, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1150)
  • - A history of primary hyperparathyroidism
  • - A history of osteoporosis for which calcium and Vitamin D treatment are mandatory
  • - A history of another granulomatous diseases (sarcoïdosis, tuberculosis)
  • - Pregnant or breastfeeding (at index date) female patients
  • - Patients undergoing other resections than ileocolonic resections
  • - Patients who prefer to use open-label vitamin D preparations

研究者

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