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Vitamin-D and Crohn´s Disease. - Article


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Vitamin B6 (Pyridoxine)


Clinical Trial: Vitamin-D and Crohn´s Disease.

This study is not yet open for patient recruitment.
Verified by University of Aarhus August 2005

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 Crohns Disease.
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.

Further Study Details: 

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

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00132184

Soren Peter G. Jorgensen, MD      +45 89 49 38 99    spgjo@as.aaa.dk

Denmark
      Aarhus University Hospital, department V., Aarhus,  8000,  Denmark
Soren Peter G. Jorgensen, MD  +45 89 49 38 99    spgjo@as.aaa.dk 
Jens F. Dahlerup, MD,  Principal Investigator

      Hospital of Silkeborg, SILKEBORG,  8600,  Denmark
Henning Glerup, MD,PhD  +45 87 222 100    mahgl@sc.aaa.dk 
Henning Glerup, MD,  Principal Investigator

      Hospital of Randers, Randers,  8900,  Denmark
Soren L. Nielsen, MD,PhD  +45 89 102 000    sni@rc.aaa.dk 
Soren L. Nielsen, MD,PhD,  Principal Investigator

Study chairs or principal investigators

Jens F. Dahlerup, MDdr.med.sc,  Principal Investigator,  Aarhus University Hospital   

More Information

Study ID Numbers:  2005-001216-50
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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October 6, 2008



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