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| Sponsored by: |
University of Aarhus |
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00132184 |
Purpose
The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.
| Condition | Intervention | Phase |
|
Crohns Disease |
Drug: Vitamin D |
Phase II Phase III |
| Genetics Home Reference related topics: | Crohn disease |
| MedlinePlus related topics: | Crohn's Disease |
| Drug Information available for: | Vitamin D Ergocalciferol |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation |
| Estimated Enrollment: | 110 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | February 2008 |
Crohns Disease is an inflammatory disease of primarily the small intestine and colon.
In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.
Eligibility
| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |||||
| Aarhus University Hospital, Department V | |||||
| Aarhus, Denmark, 8000 | |||||
| Hospital of Silkeborg | |||||
| Silkeborg, Denmark, 8600 | |||||
| Hospital of Randers | |||||
| Randers, Denmark, 8900 | |||||
| Hospital of Horsens | |||||
| Horsens, Denmark, 8700 | |||||
| University of Aarhus |
| Principal Investigator: | Jens F. Dahlerup, MD, DrMedSc | Aarhus University Hospital |
More Information
| Study ID Numbers: | 2005-001216-50 |
| First Received: | August 18, 2005 |
| Last Updated: | April 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00132184 |
| Health Authority: | Denmark: Danish Medicines Agency |
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