Clinical trial NCT02717897: Vitamin D and Disease Activity in Ulcerative Colitis
Official title: Association Between Vitamin D Level and Disease Activity in Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Both female and male participants are being studied

Brief summary: The purpose of this study is to test blood and tissue samples of people with Ulcerative Colitis (UC) to see what effects vitamin D may have on the immune system. This research is being done because it could lead to the development of new treatment for people with inflammatory Bowel Disease (IBD).

Detailed description: Patients with UC will be recruited and consented prior to colonoscopy or flexible sigmoidoscopy. All patients will be age 18 or older with a known history of UC that has been confirmed by biopsy and an extent of disease of at least 20cm proximal to the anus. Clinical data will be collected on the patient's age, disease duration, family history of IBD, smoking status and history, as well as current medications for IBD through a questionnaire. Data will also be collected regarding current vitamin D supplementation (if taking) and dose. Prior to the endoscopic procedure, peripheral blood will be drawn into two 10ml red top tubes. At the time of endoscopy, five standard size mucosal pinch biopsies will be obtained from 20cm proximal to the anus. . A bar-coded unique identifier label will be applied to each sample. One biopsy will be placed in formalin. Paraffin samples will be maintained at room temperature. Following to the endoscopic procedure, the patient's physician will complete a Mayo score based on the patients current symptoms and endoscopic disease severity. Comparison will be made between disease activity, serum serum 25 hydroxyvitamin D level, and mucosal expression of tight junction proteins as well as proinflammatory cytokines.

Eligibility criteria: Inclusion:

* Age 18 years old and over
* A diagnosis of ulcerative colitis that has been confirmed by biopsy and an extent of disease of at least 20cm proximal to the anus.

Exclusion:

* Age \<18 years old
* Diagnosis of Crohn's disease
* Diagnosis of ulcerative colitis with disease extent \<20cm proximal to the anus

Primary outcomes:
measure: 25(OH) Vitamin D level (ng/ml)
timeFrame: 1 day
Secondary outcomes:
measure: Mayo Endoscopy Score
timeFrame: 1 day
measure: mucosal zo-1 expression by real time PCR
timeFrame: 1 day
measure: mucosal occludin expression by real time PCR
timeFrame: 1 day
measure: mucosal VDR expression by real time PCR
timeFrame: 1 day
measure: mucosal claudin-2 expression by real time PCR
timeFrame: 1 day
measure: mucosal TNFa expression by real time PCR
timeFrame: 1 day
measure: mucosal IL-8 expression by real time PCR
timeFrame: 1 day
measure: mucosal VDR expression by immunohistochemistry
timeFrame: 1 day
measure: mucosal zo-1 expression by immunohistochemistry
timeFrame: 1 day
measure: mucosal occludin expression by immunohistochemistry
timeFrame: 1 day
measure: mucosal claudin-2 by immunohistochemistry
timeFrame: 1 day
Other outcomes:
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