Ulcerative Colitis and Vitamin D Supplementation

NCT ID: NCT01846026

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D

Decristol (cholecalciferol) 20000 IU per capsule

1 capsule per week

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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

Placebo

capsule with peanut oil

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Vitamin D

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

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Cholecalciferol

Eligibility Criteria

Inclusion Criteria

• Men and women older than18 years old, diagnosed with UC (either debut or relapsed chronic UC), moderate or severe, where it is an indication to treat with infliximab.

Exclusion Criteria

• Primary hyperparathyroidism (PHPT)
• Sarcoidosis
• Renal failure (serum creatinine > 125 mumol/L in men or > 105 mumol/L in women)
• Those, who use solarium routinely are not included
• Pregnant or breastfeeding women, otherwise women of fertile age must be on approved birth control methods during the study
• Renal stones last 15 years
• Cancer of any origin, diagnosed during last 5 years
• Unstable angina pectoris

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Kamycheva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Clinic, University Hospital of North Norway

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

Other Identifiers

2009-015649-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2009/1392-13 (REK)

Identifier Type: -

Identifier Source: org_study_id