The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit

Imperial College London0 个研究点目标入组 210 人开始时间: 2008年1月25日最近更新: 2019年12月10日

适应症

试验速览

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•IBDVit1/IBDVit2:
•1) Age 18 year or older.
•2) Active Crohn’s Disease Activity (CDAI) Score >200 to 450.
•2) The diagnosis of IBD and distribution of disease will have been confirmed during the course of their diagnostic investigations including endoscopic and histological parameters compatible with this diagnosis.
•3) The participant must be able to fully understand patient information sheet and sign an informed consent form
•4) Patients will be on a stable dose of the following medications prior to inclusion
•- 5-aminosalicylates (=4 weeks)
•- Thiopurines (=8 weeks).
•- No corticosteroids (=4 weeks)
•- No biological agents (=8 weeks)
•As IBDVit 1 and 2 plus;
•1) Remission in Crohn's Disease (CDAI <150) and Ulcerative Colitis Simple Clinical Colitis Score (SCCAI) <5.
•2) Clinical relapse episode of IBD within the previous 2 years.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1) Patients unable to give informed written consent;
•2) Co-existence of any other chronic inflammatory condition e.g. rheumatoid arthritis;
•3) Failure to meet above inclusion criteria medication regime as described above;
•4) Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity (e.g. Primary hyperparathyroidism);
•5) Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy,active TB, sarcoidosis or lymphoma or other granbulomatous disease;
•6) Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab);
•7) Biochemical disturbance at enrolment: serum corrected calcium > 2.66 mmol/L) or serum creatinine >250 micromol/L;
•8) Pregnancy or breast-feeding.

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