Vitamin D Treatment for Crohn´s Disease
- Conditions
- Crohns Disease
- Registration Number
- NCT00132184
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- 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
- Hypercalcemia
- Short bowel syndrome
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Relapse rate within 1 year treatment; CDAI>220
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Aarhus University Hospital, Department V
🇩🇰Aarhus, Denmark
Hospital of Horsens
🇩🇰Horsens, Denmark
Hospital of Randers
🇩🇰Randers, Denmark
Hospital of Silkeborg
🇩🇰Silkeborg, Denmark