Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.

Conditions: lcerative colitis

Registration Number: EUCTR2009-015649-21-NO

Lead Sponsor: Medical clinic, University Hospital of North Norway

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

males and females 18-75 years old with active ulcerative colitis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known diabetes, coronary infarction or stroke in the last 12 months, cancer diagnoses the last 5 years, renal stone last 15 months, solarium more than once weekly, planning more than 4 weeks in a tropical country the enxt 6 months, pregnant or lactating women, women of fertile age without safe pregnancy prevention (birth control pill, IUD). Those using psycopharmaca or vitamin D on prescription, those taking vitamin D supplementation more than 400 IU per day. nut allergy, serum creatinine levels above 130 umol/l for males and > 110 umol/l for females. subjects with primary hyperparathyroidism, subjects with sarcoidosis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: After the 12 months the maintainance of the remission and frequency of relapses in patients with active ulcerative colitis, receiving standart therapy with Infiximab, i those given vitamin D or placebo.;Secondary Objective: Cytokines respons in colonic mucosa after 12 months in patient with active uclerative colitis treated with and without vitamon d along with standart therapy with Infliximab;Primary end point(s): the duration of remisjon<br>the number of relapses

Secondary Outcome Measures