Vitamin D and Disease Activity in Ulcerative Colitis

Association Between Vitamin D Level and Disease Activity in Ulcerative Colitis

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).

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 248

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Both female and male participants are being studied

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
25(OH) Vitamin D level (ng/ml)	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Mayo Endoscopy Score	1 day
mucosal zo-1 expression by real time PCR	1 day
mucosal occludin expression by real time PCR	1 day
mucosal VDR expression by real time PCR	1 day
mucosal claudin-2 expression by real time PCR	1 day
mucosal TNFa expression by real time PCR	1 day
mucosal IL-8 expression by real time PCR	1 day
mucosal VDR expression by immunohistochemistry	1 day
mucosal zo-1 expression by immunohistochemistry	1 day
mucosal occludin expression by immunohistochemistry	1 day
mucosal claudin-2 by immunohistochemistry	1 day

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 24, 2016

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 11-0202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO