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Vitamin D Treatment in Ulcerative Colitis (Vitamin D)

Primary Purpose

Ulcerative Colitis, Inflammatory Bowel Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Inflammatory Bowel disease, IBD, Vitamin D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be over 18 years of age
  • have a diagnosis of UC as confirmed by histology.
  • UC patients must have active but mild disease as confirmed by a Mayo Clinic endoscopy score from 2-4,
  • not requiring medication adjustment during the trial.
  • Patients must be capable of understanding the purpose, risks and expectations of study participation and willing to provide written informed consent.

Exclusion Criteria:

  • Individuals on vitamin D or laxative therapy (except for purposes of endoscopy preparation),
  • UC patients with fulminant colitis or active C difficile or other colonic infections,
  • age<18 year old,
  • individuals with bleeding disorders will be excluded from the study.

Sites / Locations

  • NorthShore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

Subjects will take 1 pill per day for 8 weeks.

Subjects will be asked to take 1 pill per day for 8 weeks.

Outcomes

Primary Outcome Measures

Mucosal Permeability
The primary endpoint of the trial is the change in colonic permeability as a global assessment of vitamin D3 effects throughout the colon in patients with Ulcerative Colitis.

Secondary Outcome Measures

Mucosal tight junction protein expression
Secondary endpoints will be changes in mucosal tight junction protein expression, and their relationship to serum vitamin D level, VDR expression, inflammatory cytokines, and histologic inflammation.

Full Information

First Posted
July 11, 2012
Last Updated
December 1, 2014
Sponsor
University of Chicago
Collaborators
North Shore University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01640496
Brief Title
Vitamin D Treatment in Ulcerative Colitis
Acronym
Vitamin D
Official Title
Vitamin D Treatment in Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
North Shore University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 D3 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
The primary endpoint of the trial is the change in colonic permeability as a global assessment of vitamin D3 effects throughout the colon in patients with Ulcerative Colitis. Secondary endpoints will be changes in colonic tight junction protein expression, and their relationship to serum vitamin D level, VDR expression, inflammatory cytokines, and histologic inflammation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Inflammatory Bowel Disease
Keywords
Ulcerative Colitis, Inflammatory Bowel disease, IBD, Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Subjects will take 1 pill per day for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be asked to take 1 pill per day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
3000 IU Vitamin D3 tablets (Cholecalciferol) will be used. 28 pills per bottle. Subjects will be given 2 bottles to be taken for the duration of this study.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be given to subjects. 28 pills per bottle. Subjects will be given 2 bottles to be taken for the duration of this study.
Primary Outcome Measure Information:
Title
Mucosal Permeability
Description
The primary endpoint of the trial is the change in colonic permeability as a global assessment of vitamin D3 effects throughout the colon in patients with Ulcerative Colitis.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Mucosal tight junction protein expression
Description
Secondary endpoints will be changes in mucosal tight junction protein expression, and their relationship to serum vitamin D level, VDR expression, inflammatory cytokines, and histologic inflammation.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be over 18 years of age have a diagnosis of UC as confirmed by histology. UC patients must have active but mild disease as confirmed by a Mayo Clinic endoscopy score from 2-4, not requiring medication adjustment during the trial. Patients must be capable of understanding the purpose, risks and expectations of study participation and willing to provide written informed consent. Exclusion Criteria: Individuals on vitamin D or laxative therapy (except for purposes of endoscopy preparation), UC patients with fulminant colitis or active C difficile or other colonic infections, age<18 year old, individuals with bleeding disorders will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Pekow, M.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Treatment in Ulcerative Colitis

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