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

This study has been withdrawn prior to enrollment.
(Unable to recruit adequate trial participants)
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00672763
First received: May 2, 2008
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Crohn's Disease
 Drug: Colecalciferol D3 (Vigantol Oil)
Drug: Medium chain triglycerides
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Clinical Remission (CDAI score <150) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in CDAI suggestive of a clinical improvement. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Reduction in serum C-reactive protein. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Reduction of faecal calprotectin levels [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Clinical Remission (CDAI score <150) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).
 Drug: 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).
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
  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)
Other Names:
  • CalcichewD3Forte (Calcium and Vitamin D3)
  • Migliol Oil (Placebo)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672763

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

No publications provided

Responsible Party: Dr. Andrew N. Milestone, Imperial College London
ClinicalTrials.gov Identifier: NCT00672763     History of Changes
Other Study ID Numbers: VITDIBD1, EudraCT: 2007-006692-37
Study First Received: May 2, 2008
Last Updated: June 21, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Crohn's Disease
Inflammatory Bowel Disease
Vitamin D
Randomised
Placebo

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013