This trial is active, not recruiting.

Condition crohns disease
Treatment vitamin d
Phase phase 2/phase 3
Sponsor University of Aarhus
Start date September 2005
End date February 2008
Trial size 110 participants
Trial identifier NCT00132184, 2005-001216-50


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Relapse rate within 1 year treatment; CDAI>220
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation
Principal investigator Jens F. Dahlerup, MD, DrMedSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by University of Aarhus.