Vitamin D Treatment for Crohn´s Disease

Crohns Disease Clinical Trial

Official title:

Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00132184
• Other study ID #: 2005-001216-50
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: August 18, 2005
• Last updated: April 12, 2007
• Start date: September 2005
• Est. completion date: February 2008

Study information

• Verified date: April 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohns Disease

Intervention

Drug:
• Vitamin D

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department V	Aarhus
Denmark	Hospital of Horsens	Horsens
Denmark	Hospital of Randers	Randers
Denmark	Hospital of Silkeborg	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse rate within 1 year treatment; CDAI>220