Ulcerative Colitis and Vitamin D Supplementation

Ulcerative Colitis Clinical Trial

Official title:

Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01846026
• Other study ID #: 2009/1392-13 (REK)
• Secondary ID: 2009-015649-21
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: April 30, 2013
• Last updated: June 1, 2015
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Vitamin D
compare how vitamin D influences the course of ulcerative colitis versus placebo
• placebo

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with remission	Mandatory criterion of remission: clinical remission (defined as Mayo score <= 1, including endoscopic findings) and non-mandatory: laboratory (calprotectin < 100, WBC and SR within reference range). These criteria will be assessed at 12 month after the start of intervention	12 months after start of intervention	No
Secondary	change in fecal calprotectin	change in fecal calprotectin compared to baseline value	12 months after start of intervention	No
Secondary	change in bone mineral density (whole body)	change in bone mineral density in whole body, measured with DEXA (t-score and z-score)	12 months after the start of intervention	No
Secondary	change in fecal calprotectin	change in fecal calprotectin	3 months	No
Secondary	change in tnf-alpha levels in colonic mucosa	change in mucosal tnf-alpha levels. Biopsies will be taken with the forceps from the colonic mucosa (colon sigmoid) and stored in RNA later media for the further analysis for TNF alpha concentration with PCR method.	3 months	No
Secondary	change in tnf-alpha (in colonic mucosa)	Biopsies and analysis will be carried out as described ata 3 months follow-up	12 months after baseline	No