Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease (IBDVit1)

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Colecalciferol D3 (Vigantol Oil); Drug: Medium chain triglycerides

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).	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).; Other Names: CalcichewD3Forte (Calcium and Vitamin D3); Vigantol Oil (Colecalciferol D3)
Placebo Comparator: B; Standard corticosteroid treatment PLUS placebo (Migliol Oil)	Drug: 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); Other Names: CalcichewD3Forte (Calcium and Vitamin D3); Migliol Oil (Placebo)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Andrew N Milestone, BSc(Hons) MBBS MRCP, Imperial College London (Hammersmith and St. Mark's Hospitals); Study Chair: Subrata Ghosh, MD (Edin) FRCP, FRCP (Edin), Imperial College London (Hammersmith Hospital); Study Director: Ailsa L Hart, BA(Hons), BM BCh, MRCP, PhD, Imperial College London (St. Mark's Hospital)

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): May 1, 2010
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: May 2, 2008
• First Submitted That Met QC Criteria: May 5, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Vitamin D; Inflammatory Bowel Disease; Crohn's Disease; Placebo; Randomised
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Calcium; Vitamins; Calcium, Dietary; Ergocalciferols
• Other Study ID Numbers: VITDIBD1; EudraCT: 2007-006692-37