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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015649-21-NO

Enrollment

200

Registered

2009-09-16

Start date

2009-10-21

Completion date

Unknown

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

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 u

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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 the number of relapses	—

Measure

Time frame

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 the number of relapses

—

Countries

Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026