Vitamin D Treatment for Crohn´s Disease

University of Aarhus

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Crohns Disease

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT00132184

2005-001216-50

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind