Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

• Status: Withdrawn
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Calcium; Calcium, Dietary; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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.