Clinical trial NCT01846026: Ulcerative Colitis and Vitamin D Supplementation
Official title: Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: number of patients with remission
timeFrame: 12 months after start of intervention
Secondary outcomes:
measure: change in fecal calprotectin
timeFrame: 12 months after start of intervention
measure: change in bone mineral density (whole body)
timeFrame: 12 months after the start of intervention
measure: change in fecal calprotectin
timeFrame: 3 months
measure: change in tnf-alpha levels in colonic mucosa
timeFrame: 3 months
measure: change in tnf-alpha (in colonic mucosa)
timeFrame: 12 months after baseline
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: Medical Clinic, University Hospital of North Norway
name: Elena Kamycheva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: