The purpose of this study is to determine whether the addition of vitamin D to standard corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory Bowel Disease (IBD).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
1. Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; 2. Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; 3. Colecalciferol 100,000iU orally once fortnightly for 4 weeks (2 doses).
1. Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; 2. Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; 3. Migliol Oil 5ml oral fortnightly (2 doses)
Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)
London, London, United Kingdom
St. Mark's Hospital
Harrow, Middlesex, United Kingdom
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
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