Clinical trial NCT00672763: Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Inflammatory Bowel Disease
Vitamin D
Randomised
Placebo
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Clinical Remission (CDAI score <150)
timeFrame: 4 Weeks
Secondary outcomes:
measure: Reduction in CDAI suggestive of a clinical improvement.
timeFrame: Week 4
measure: Reduction in serum C-reactive protein.
timeFrame: Week 4
measure: Reduction of faecal calprotectin levels
timeFrame: Week 4
measure: Clinical Remission (CDAI score <150)
timeFrame: Week 6
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: St. Mark's Hospital
state: Middlesex
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)
Study officials:
affiliation: Imperial College London (Hammersmith and St. Mark's Hospitals)
name: Andrew N Milestone, BSc(Hons) MBBS MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London (Hammersmith Hospital)
name: Subrata Ghosh, MD (Edin) FRCP, FRCP (Edin)
role: STUDY_CHAIR
affiliation: Imperial College London (St. Mark's Hospital)
name: Ailsa L Hart, BA(Hons), BM BCh, MRCP, PhD
role: STUDY_DIRECTOR
References: