Crohns Disease
Conditions
Keywords
Vitamin D, Crohns Disease
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.
Interventions
DRUGVitamin D
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate within 1 year treatment; CDAI>220 | — |
Countries
Denmark
Outcome results
None listed