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OpenTrials
Completed

NCT Number: NCT02717897

Vitamin D 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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This study is not interventional

Primary outcomes

  1. 25(OH) Vitamin D level (ng/ml)

    Time frame: 1 day

Secondary outcomes

  1. Mayo Endoscopy Score

    Time frame: 1 day

  2. mucosal zo-1 expression by real time PCR

    Time frame: 1 day

  3. mucosal occludin expression by real time PCR

    Time frame: 1 day

  4. mucosal VDR expression by real time PCR

    Time frame: 1 day

  5. mucosal claudin-2 expression by real time PCR

    Time frame: 1 day

  6. mucosal TNFa expression by real time PCR

    Time frame: 1 day

  7. mucosal IL-8 expression by real time PCR

    Time frame: 1 day

  8. mucosal VDR expression by immunohistochemistry

    Time frame: 1 day

  9. mucosal zo-1 expression by immunohistochemistry

    Time frame: 1 day

  10. mucosal occludin expression by immunohistochemistry

    Time frame: 1 day

  11. mucosal claudin-2 by immunohistochemistry

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Association Between Vitamin D Level and Disease Activity in Ulcerative Colitis

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 24, 2016
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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