Vitamin D Treatment in Ulcerative Colitis (Vitamin D)
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|ClinicalTrials.gov Identifier: NCT01640496|
Recruitment Status : Withdrawn
First Posted : July 13, 2012
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Inflammatory Bowel Disease||Drug: Vitamin D3 Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vitamin D Treatment in Ulcerative Colitis|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||December 2014|
Active Comparator: Vitamin D
Subjects will take 1 pill per day for 8 weeks.
Drug: 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.
Other Name: Cholecalciferol
Placebo Comparator: Placebo
Subjects will be asked to take 1 pill per day for 8 weeks.
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.
- Mucosal Permeability [ Time Frame: 8 weeks ]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.
- Mucosal tight junction protein expression [ Time Frame: 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640496
|United States, Illinois|
|Evanston, Illinois, United States, 60201|
|Principal Investigator:||Joel Pekow, M.D.||University of Chicago|