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

Imperial College London

Status and phase: Withdrawn; Phase 4

Conditions: Crohn's Disease

Treatments: Drug: Medium chain triglycerides; Drug: Colecalciferol D3 (Vigantol Oil)

Study type: Interventional

Funder types: Other

Identifiers

NCT00672763

EudraCT: 2007-006692-37

VITDIBD1

Details and patient eligibility

About

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).

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).

Treatment:

Drug: Colecalciferol D3 (Vigantol Oil)

B

Placebo Comparator group

Description:

Standard corticosteroid treatment PLUS placebo (Migliol Oil)

Treatment:

Drug: Medium chain triglycerides