Vitamin D Treatment in Ulcerative Colitis

Study Overview
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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

Official Title
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Vitamin D Treatment in Ulcerative Colitis

Conditions
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Ulcerative Colitis, Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Vitamin D3
* Other: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>Subjects will take 1 pill per day for 8 weeks. | Drug: Vitamin D3<br>* 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.<br>* Other names: Cholecalciferol;|
| Placebo Comparator: Placebo<br>Subjects will be asked to take 1 pill per day for 8 weeks. | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Inflammatory Bowel disease, IBD, Vitamin D