NCT01846026

Ulcerative Colitis and Vitamin D Supplementation

Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased permeability. Several cytokines are described to mediate the progressive course of ulcerative colitis and it is considered nowadays an immunologic disease. Patients with UC have often low levels of vitamin D and elevated prevalence of osteoporosis. In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a direct healing action on colonic mucosa has been described in animal studies. One can therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with UC. To our knowledge, it has not been performed randomized clinical trials to study these possible effects of vitamin D and it has not been studied the effects of vitamin D on the relapse frequency and immunological composition of colic mucosa in patient with moderate to severe ulcerative colitis. Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in patients with moderate to severe ulcerative colitis: * reduces relapse frequency and increase the duration of the Infliximab induced remission * mediates and changes the cytokines composition in the colic mucosa * decreases the excretion of calprotectin in feces and reduces the concentration of inflammation markers * augments bone mass

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Vitamin D	compare how vitamin D influences the course of ulcerative colitis versus placebo
DRUG	placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-04-01
• Completion: 2016-12-01
• First posted: 2013-05-03
• Last updated: 2015-06-02

Locations

1 site across 1 country: Norway