Status:
WITHDRAWN
Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease
Lead Sponsor:
Imperial College London
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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....
Eligibility Criteria
Inclusion
- Active Crohn's Disease Activity (CDAI) Score \>200 to 450;
- Diagnosis of IBD and distribution of disease previously confirmed
- The participant able to give informed consent form;
- 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
- Unable to give informed written consent;
- Co-existence of any other chronic inflammatory conditions
- Failure to meet concurrent IBD medication criteria;
- Hypercalcaemia (Corrected serum calcium \> 2.66 mmol/L) or history of vitamin D hypersensitivity;
- 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;
- Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab);
- Biochemical disturbance at enrolment: serum corrected calcium \> 2.66 mmol/L) or serum creatinine \>250 micromol/L;
- Pregnancy or breast-feeding.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00672763
Start Date
May 1 2008
End Date
May 1 2010
Last Update
June 8 2015
Active Locations (2)
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1
Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)
London, London, United Kingdom
2
St. Mark's Hospital
Harrow, Middlesex, United Kingdom