Vitamin D and Disease Activity in Ulcerative Colitis

July 1, 2025 updated by: University of Chicago

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
25(OH) Vitamin D level (ng/ml)
Time Frame: 1 day
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mayo Endoscopy Score
Time Frame: 1 day
1 day
mucosal zo-1 expression by real time PCR
Time Frame: 1 day
1 day
mucosal occludin expression by real time PCR
Time Frame: 1 day
1 day
mucosal VDR expression by real time PCR
Time Frame: 1 day
1 day
mucosal claudin-2 expression by real time PCR
Time Frame: 1 day
1 day
mucosal TNFa expression by real time PCR
Time Frame: 1 day
1 day
mucosal IL-8 expression by real time PCR
Time Frame: 1 day
1 day
mucosal VDR expression by immunohistochemistry
Time Frame: 1 day
1 day
mucosal zo-1 expression by immunohistochemistry
Time Frame: 1 day
1 day
mucosal occludin expression by immunohistochemistry
Time Frame: 1 day
1 day
mucosal claudin-2 by immunohistochemistry
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-0202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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