Crohn's Disease
Conditions
Keywords
Crohn's Disease, Inflammatory Bowel Disease, Vitamin D, Randomised, Placebo
Brief summary
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).
Detailed description
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).
Interventions
DRUGColecalciferol D3 (Vigantol Oil)
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)
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Active Crohn's Disease Activity (CDAI) Score \>200 to 450; 2. Diagnosis of IBD and distribution of disease previously confirmed 3. The participant able to give informed consent form; 4. Stable doses of the following concurrent IBD medications prior to inclusion: * 5-aminosalicylates (≥4 weeks) * Thiopurines (≥8 weeks) * No corticosteroids (within 4 weeks) * No biological agents (within 8 weeks).
Exclusion criteria
1. Unable to give informed written consent; 2. Co-existence of any other chronic inflammatory conditions 3. Failure to meet concurrent IBD medication criteria; 4. Hypercalcaemia (Corrected serum calcium \> 2.66 mmol/L) or history of vitamin D hypersensitivity; 5. Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy, active TB, sarcoidosis or lymphoma or other granulomatous 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Remission (CDAI score <150) | 4 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in CDAI suggestive of a clinical improvement. | Week 4 |
| Reduction in serum C-reactive protein. | Week 4 |
| Reduction of faecal calprotectin levels | Week 4 |
| Clinical Remission (CDAI score <150) | Week 6 |
Countries
United Kingdom
Outcome results
None listed