Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

NCT ID: NCT00672763

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-05-31

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).

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).

Group Type: ACTIVE_COMPARATOR

Colecalciferol D3 (Vigantol Oil)

Intervention Type: DRUG

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).

B

Standard corticosteroid treatment PLUS placebo (Migliol Oil)

Group Type: PLACEBO_COMPARATOR

Medium chain triglycerides

Intervention Type: DRUG

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)

Interventions

Colecalciferol 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).

Intervention Type: DRUG

Medium chain triglycerides

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)

Intervention Type: DRUG

Other Intervention Names

CalcichewD3Forte (Calcium and Vitamin D3); Vigantol Oil (Colecalciferol D3); CalcichewD3Forte (Calcium and Vitamin D3); Migliol Oil (Placebo)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Imperial College London

Principal Investigators

Andrew N Milestone, BSc(Hons) MBBS MRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London (Hammersmith and St. Mark's Hospitals)

Subrata Ghosh, MD (Edin) FRCP, FRCP (Edin)

Role: STUDY_CHAIR

Imperial College London (Hammersmith Hospital)

Ailsa L Hart, BA(Hons), BM BCh, MRCP, PhD

Role: STUDY_DIRECTOR

Imperial College London (St. Mark's Hospital)

Locations

Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)

London, London, United Kingdom

St. Mark's Hospital

Harrow, Middlesex, United Kingdom

Countries

United Kingdom

Other Identifiers

EudraCT: 2007-006692-37

Identifier Type: -

Identifier Source: secondary_id

VITDIBD1

Identifier Type: -

Identifier Source: org_study_id