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

Academic Medical Center0 个研究点目标入组 142 人开始时间: 2014年9月15日最近更新: 2018年1月8日

适应症

试验速览

暂无简介。

•-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
•-Serum calcium levels at screening not exceeding upper limit of normal according to local lab reference ranges
•-Being able to resume oral intake within 2 weeks after surgery
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 142
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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

发起方

Academic Medical Center