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

Phase 1

• Conditions: IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission; MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease; MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis

• Registration Number: EUCTR2007-006692-37-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

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)

IBDVit3:-
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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified