the Effect of Vitamin D in Crohn's Disease

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of 12-week goal-directed therapy in the treatment of refractory inflammatory patients, and to initially explore treatment options. Patients with potential risk factors for recurrence after surgery for Crohn's disease and a serum 25(OH)D concentration <75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100-125 nmol/L.

Detailed Description
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The patients received oral liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL). A target 25(OH)D of 100-125 nmol/L was planned and the dose titrated 4-weekly. Patients were evaluated at week 0 (screening visit), then 2- weekly until week 12, and at a follow-up visit at week 16. Key study endpoints were change in total 25(OH)D and attainment of level of 100e125 nmol/L. Intestinal inflammation was assessed via clinical disease activity (CDAI), faecal calprotectin (Calprotectin ELISA, Buhlmann, Basel, Switzerland), and circulating inflammatory markers (platelet count, serum albumin and C- reactive protein). Safety was assessed by direct questioning and 24- h urinary calcium excretion . Compliance was checked by dosing diaries completed by patients and measuring remaining cholecalciferol in bottles of the study drug. Statistical analyses were performed using SPSS v20 (IBM Corporation, 2011) and GraphPad Prism v5.04 (Graphpad software, 2010). Dependent and independent samples t-tests, analysis of variance (ANOVA) and KruskaleWallis tests were used where appropriate. Associations with rise in 25(OH)D were examined by bivariate correlations. A p-value of 0.05 was considered statistically significant.

Official Title
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the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease

Conditions
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Vitamin D Deficiency, Crohn Disease

Intervention / Treatment
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* Drug: Vitamin D
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Crohn's Disease Must be able to swallow tablets Have certain factors increase the risk of surgery in CD. include: current smoking fistulizing and stricturing disease behaviour early steroid use (medical need for steroids for treatment of first flare) disease in the end of the small bowel (i.e. ileum) disease in the middle part of the small bowel (i.e. jejunum), and young age at the time of the diagnosis. Exclusion Criteria: Other serious gastrointestinal diseases pregnancy hypercalcemia hyperparathyroidism chronic kidney disease and cardiovascular disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>The physical properties such as appearance, size, color, dosage form, weight, taste and odor of placebo should be as much as possible as the test drug, but should not contain the Vitamin D (such as tablets containing lactose). | Drug: Placebo oral capsule<br>* the capsule contain nothing<br>* Other names: Placebo;|
| Experimental: Vitamin D group<br>Liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL) | Drug: Vitamin D<br>* patients with refractory Crohn disease and a serum 25(OH)D concentration <75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100e125 nmol/L.<br>* Other names: VD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical disease activity | CDAI score | up to one year | 
| Fecal calprotectin | Calprotectin is a calcium-containing protein derived from neutrophils and macrophages. Its expression is tissue or cell specific and can be used as a marker for activation of acute inflammatory cells. | up to one year | 
| C-reactive protein | circulating inflammatory markers | up to one year | 
| Discomportant complaint | Incidence of Treatment Adverse Events | up to one year | 
| 24-hour urinary calcium | Determination of calcium in urine for 24 hours | up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Crohn Disease, recurrence