NCT02717897

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

March 10, 2016

Last Update Submit

July 1, 2025

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • 25(OH) Vitamin D level (ng/ml)

    1 day

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Interventions

No interventionOTHER

This study is not interventional

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Both female and male participants are being studied

You may qualify if:

  • 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.

You may not qualify if:

  • Age \<18 years old
  • Diagnosis of Crohn's disease
  • Diagnosis of ulcerative colitis with disease extent \<20cm proximal to the anus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Serum 2. Colon mucosal RNA 3. Formalin fixed paraffin embedded colon biopsy

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 24, 2016

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share