Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- University of Aarhus
- Enrollment
- 110
- Locations
- 4
- Primary Endpoint
- Relapse rate within 1 year treatment; CDAI>220
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Relapse rate within 1 year treatment; CDAI>220
Secondary Outcomes
No secondary outcomes reported