Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease (IBDVit1)
|Crohn's Disease||Drug: Colecalciferol D3 (Vigantol Oil) Drug: Medium chain triglycerides||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease|
- Clinical Remission (CDAI score <150) [ Time Frame: 4 Weeks ]
- Reduction in CDAI suggestive of a clinical improvement. [ Time Frame: Week 4 ]
- Reduction in serum C-reactive protein. [ Time Frame: Week 4 ]
- Reduction of faecal calprotectin levels [ Time Frame: Week 4 ]
- Clinical Remission (CDAI score <150) [ Time Frame: Week 6 ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Active Comparator: A
Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).
Drug: Colecalciferol D3 (Vigantol Oil)
Placebo Comparator: B
Standard corticosteroid treatment PLUS placebo (Migliol Oil)
Drug: Medium chain triglycerides
Crohn's Disease is a form of Inflammatory Bowel Disease (IBD). It is caused by abnormal immune-mediated gut inflammation and is both chronic and difficult to treat. Symptoms are often unpleasant (e.g. abdominal pain, diarrhoea, disfiguring fistulation) and often lead to surgery to remove diseased bowel.
There is emerging evidence that Vitamin D, a nutrient largely produced in the skin upon exposure to sun-light, may possess properties regulating the immune system in IBD. In addition, vitamin D deficiency appears common in Inflammatory Bowel Disease.
This study aims to determine if the addition of vitamin D to standard corticosteroid treatment in active Crohn's Disease helps to achieve remission (resolution of symptoms).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672763
|St. Mark's Hospital|
|Harrow, Middlesex, United Kingdom|
|Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)|
|London, United Kingdom|
|Principal Investigator:||Andrew N Milestone, BSc(Hons) MBBS MRCP||Imperial College London (Hammersmith and St. Mark's Hospitals)|
|Study Chair:||Subrata Ghosh, MD (Edin) FRCP, FRCP (Edin)||Imperial College London (Hammersmith Hospital)|
|Study Director:||Ailsa L Hart, BA(Hons), BM BCh, MRCP, PhD||Imperial College London (St. Mark's Hospital)|