Vitamin D and Disease Activity in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Association Between Vitamin D Level and Disease Activity in Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717897
• Other study ID #: 11-0202
• Status: Completed
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: February 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• No intervention
This study is not interventional

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25(OH) Vitamin D level (ng/ml)		1 day
Secondary	Mayo Endoscopy Score		1 day
Secondary	mucosal zo-1 expression by real time PCR		1 day
Secondary	mucosal occludin expression by real time PCR		1 day
Secondary	mucosal VDR expression by real time PCR		1 day
Secondary	mucosal claudin-2 expression by real time PCR		1 day
Secondary	mucosal TNFa expression by real time PCR		1 day
Secondary	mucosal IL-8 expression by real time PCR		1 day
Secondary	mucosal VDR expression by immunohistochemistry		1 day
Secondary	mucosal zo-1 expression by immunohistochemistry		1 day
Secondary	mucosal occludin expression by immunohistochemistry		1 day
Secondary	mucosal claudin-2 by immunohistochemistry		1 day