Back to resultsVitamin D Treatment for Crohn´s Disease
Primary Purpose
Crohns Disease
Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Crohns Disease focused on measuring Vitamin D, Crohns Disease
Eligibility Criteria
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
Sites / Locations
- Aarhus University Hospital, Department V
- Hospital of Horsens
- Hospital of Randers
- Hospital of Silkeborg
Outcomes
Primary Outcome Measures
Relapse rate within 1 year treatment; CDAI>220
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00132184
Brief Title
Vitamin D Treatment for Crohn´s Disease
Official Title
Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohns Disease
Keywords
Vitamin D, Crohns Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
110 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Primary Outcome Measure Information:
Title
Relapse rate within 1 year treatment; CDAI>220
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens F. Dahlerup, MD, DrMedSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Department V
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Hospital of Horsens
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Hospital of Randers
City
Randers
ZIP/Postal Code
8900
Country
Denmark
Facility Name
Hospital of Silkeborg
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Treatment for Crohn´s Disease
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