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Vitamin D and Disease Activity in Ulcerative Colitis

Association Between Vitamin D Level and Disease Activity in Ulcerative Colitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02717897
Enrollment
248
Registered
2016-03-24
Start date
2011-11-30
Completion date
2013-05-31
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

OTHERNo intervention

This study is not interventional

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
25(OH) Vitamin D level (ng/ml)1 day

Secondary

MeasureTime frame
mucosal occludin expression by real time PCR1 day
mucosal VDR expression by real time PCR1 day
mucosal claudin-2 expression by real time PCR1 day
mucosal TNFa expression by real time PCR1 day
mucosal IL-8 expression by real time PCR1 day
mucosal zo-1 expression by real time PCR1 day
mucosal zo-1 expression by immunohistochemistry1 day
mucosal occludin expression by immunohistochemistry1 day
mucosal claudin-2 by immunohistochemistry1 day
Mayo Endoscopy Score1 day
mucosal VDR expression by immunohistochemistry1 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026