Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3

• Conditions: lcerative colitis - in remissionCrohn's Disease - in remission; MedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitis; MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2008-001467-10-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-28
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1) Patients must be in clinical remission based on a Crohn’s Disease Activity (CDAI) Score <150 (Crohn's Disease) or Simple Clinical Colitis Activity Index <5 (Ulcerative Colitis);
2) Age 18 years or older;
3) Diagnosis of Inflammatory Bowel Disease and distribution of disease will have been confirmed during the course of previous diagnostic investigations including endoscopic and histological parameters compatible with this diagnosis;
4) Patients with a history of at least 1 clinical relapse episode in the last 2 years;
5) The participant must be able to fully understand patient information sheet and sign an informed consent form;
6) Patients must be in remission and on stable doses of standard maintenance therapy prior to inclusion including:
- 5-aminosalicylates (Stable dose for 4 weeks)
- Thiopurines (Stable dose for 8 weeks)
- Off corticosteroids (for at least 4 weeks)
- Off biological agents (for at least 8 weeks).
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 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 following: 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;
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