Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Colecalciferol D3 (Vigantol Oil)
* Drug: Medium chain triglycerides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active Crohn's Disease Activity (CDAI) Score >200 to 450; Diagnosis of IBD and distribution of disease previously confirmed The participant able to give informed consent form; 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: Unable to give informed written consent; Co-existence of any other chronic inflammatory conditions Failure to meet concurrent IBD medication criteria; Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity; 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; Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab); Biochemical disturbance at enrolment: serum corrected calcium > 2.66 mmol/L) or serum creatinine >250 micromol/L; Pregnancy or breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol). | Drug: Colecalciferol D3 (Vigantol Oil)<br>* Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; Colecalciferol 100,000iU orally once fortnightly for 4 weeks (2 doses).<br>* Other names: Vigantol Oil (Colecalciferol D3);|
| Placebo Comparator: B<br>Standard corticosteroid treatment PLUS placebo (Migliol Oil) | Drug: Medium chain triglycerides<br>* Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; Migliol Oil 5ml oral fortnightly (2 doses)<br>* Other names: Migliol Oil (Placebo);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission (CDAI score <150) |  | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Inflammatory Bowel Disease, Vitamin D, Randomised, Placebo