Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

Phase 4

Withdrawn

• Conditions: Crohn's Disease
• Interventions: Drug: Colecalciferol D3 (Vigantol Oil); Drug: Medium chain triglycerides

• Registration Number: NCT00672763
• Lead Sponsor: Imperial College London

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).

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-06
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2011-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Colecalciferol D3 (Vigantol Oil)	Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).
B	Medium chain triglycerides	Standard corticosteroid treatment PLUS placebo (Migliol Oil)

Primary Outcome Measures

Name	Time	Method
Clinical Remission (CDAI score <150)	4 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

St. Mark's Hospital; 🇬🇧 Harrow, Middlesex, United Kingdom

Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals); 🇬🇧 London, United Kingdom