Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

Crohn's Disease Clinical Trial

— IBDVit1  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00672763
• Other study ID #: VITDIBD1
• Secondary ID: EudraCT: 2007-00
• Status: Withdrawn
• Phase: Phase 4
• First received: May 2, 2008
• Last updated: June 3, 2015
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: June 2011
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Colecalciferol D3 (Vigantol Oil)
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).
• Medium chain triglycerides
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)

Locations

Country	Name	City	State
United Kingdom	St. Mark's Hospital	Harrow	Middlesex
United Kingdom	Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission (CDAI score <150)		4 Weeks	No
Secondary	Reduction in CDAI suggestive of a clinical improvement.		Week 4	No
Secondary	Reduction in serum C-reactive protein.		Week 4	No
Secondary	Reduction of faecal calprotectin levels		Week 4	No
Secondary	Clinical Remission (CDAI score <150)		Week 6	No