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.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-015649-21-NO
• Date of registration: 16/09/2009
• Prospective Registration: Yes
• Primary sponsor: Medical clinic, University Hospital of North Norway
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 21/10/2009
• Target sample size: 200
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015649-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Norway

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative colitis

Intervention(s)

Trade Name: Dekristol
Product Name: cholecalciferol
Product Code: na
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

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.

Primary end point(s): the duration of remisjon
the number of relapses

Secondary ID(s)

Kamycheva/2009/1