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Ulcerative Colitis and Vitamin D Supplementation

NCT01846026 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-06-02

No results posted yet for this study

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

Interventions

DRUG

Vitamin D

compare how vitamin D influences the course of ulcerative colitis versus placebo

DRUG

placebo

Sponsors & Collaborators

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Elena Kamycheva, MD, PhD · Medical Clinic, University Hospital of North Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-04-30
Completion
2016-12-31

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846026 on ClinicalTrials.gov