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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 24 July 2012
Main ID:  EUCTR2008-001466-93-GB
Date of registration: 28/03/2008
Prospective Registration: Yes
Primary sponsor: Imperial College London
Public title:
Scientific title: Trial of adjuvant vitamin D with Infliximab in active Crohn's Disease (IBDVit2). - IBDVit2
Date of first enrolment: 30/04/2008
Target sample size: 40
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001466-93
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1) Age 18 year or older;
2) Active Crohn’s Disease Activity (CDAI) Score >200 to 450;
3) 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;
4) The participant must be able to fully understand patient information sheet and sign an informed consent form;
5) Patients must be on a stable dose of the following medications prior to inclusion. Patients will be required to be established on a stable dose of corticosteroids of 20mg or less daily for at least 2 weeks prior to enrolment. Patients will also be required to be on a stable doses of immunosuppressants or 5-aminosalicylates as follows: 5-aminosalicylates (=4 weeks) and thiopurines (=8 weeks). No other biological agents must have been administered within 8 weeks of enrolment.

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 regimen as described in the inclusion criteria.
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 followwing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, 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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Active Crohn's Disease
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Intervention(s)

Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM
Pharmaceutical Form: Oral liquid
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To demonstrate the efficacy of colecalciferol (Vitamin D) as an adjuvant treatment to Infliximab in the induction of remission in active Crohn's Disease.
Primary end point(s): Primary Efficacy Endpoint:
Clinical Remission at end of week 4 based on CDAI score <150
Secondary Objective: Demonstration of the ability of vitamin D to improve symptoms and inflammatory markers in active Crohn's Disease.
Secondary Outcome(s)
Secondary ID(s)
IBDVit2
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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