Vitamin D Treatment for Crohn´s Disease
This trial is active, not recruiting.
|Phase||phase 2/phase 3|
|Sponsor||University of Aarhus|
|Start date||September 2005|
|End date||February 2008|
|Trial size||110 participants|
|Trial identifier||NCT00132184, 2005-001216-50|
The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Aarhus, Denmark||Aarhus University Hospital, Department V||no longer recruiting|
|Horsens, Denmark||Hospital of Horsens||no longer recruiting|
|Randers, Denmark||Hospital of Randers||no longer recruiting|
|Silkeborg, Denmark||Hospital of Silkeborg||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Relapse rate within 1 year treatment; CDAI>220
Male or female participants from 18 years up to 90 years old.
Inclusion Criteria: - Crohn's disease - Inactive Crohn's disease for at least 4 weeks - Crohn's Disease Activity Index (CDAI) < 150 - C-reactive protein within normal range - Serum albumin within normal range Exclusion Criteria: - Hypercalcemia - Short bowel syndrome - Pregnancy
|Official title||Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation|
|Principal investigator||Jens F. Dahlerup, MD, DrMedSc|
|Description||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.|
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