Vitamin D Treatment in Ulcerative Colitis

NCT ID: NCT01640496

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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Ulcerative Colitis Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

Subjects will take 1 pill per day for 8 weeks.

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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Vitamin D3

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 DRUG

Placebo

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.

Intervention Type OTHER

Other Intervention Names

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Cholecalciferol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Shore University Hospital

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel Pekow, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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NorthShore

Evanston, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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11-0542

Identifier Type: -

Identifier Source: org_study_id