Vitamin B6 (Pyridoxine) |
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Clinical Trial: Vitamin-D and Crohn´s Disease.
This study is not yet open for patient recruitment.
Verified by University of Aarhus August 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Crohn Disease | Drug: Vitamin-D | Phase II |
MedlinePlus related topics: Crohn''''s Disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: Remision Keeping and Remision Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation.
Expected Total Enrollment: 100
Study start: September 2005
Crohns Disease is an inflammatory disease of primarily the small intestine and colon.
Recent years scientist has hypothesized low blood vitamin-D levels playing a role in the development of autoimmune disease, 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 weeks.
Eligibility
Inclusion Criteria:
- Crohn´s disease
- Inactive Crohns disease for at least 4 weeks
- CDAI<150
- C-reactive protein within normal range
- serum-albumine within normal range
Exclusion Criteria:
- Hypercalcemia
- Short bowel syndrome
- Pregnancy
Location and Contact Information
Denmark
Aarhus University Hospital, department V., Aarhus, 8000, Denmark
Jens F. Dahlerup, MD, Principal Investigator
Hospital of Silkeborg, SILKEBORG, 8600, Denmark
Henning Glerup, MD, Principal Investigator
Hospital of Randers, Randers, 8900, Denmark
Soren L. Nielsen, MD,PhD, Principal Investigator
Jens F. Dahlerup, MDdr.med.sc, Principal Investigator, Aarhus University Hospital
More Information
Last Updated: August 18, 2005
Record first received: August 18, 2005
ClinicalTrials.gov Identifier: NCT00132184
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-23

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