Vitamin D Treatment in Ulcerative Colitis (Vitamin D)
|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Recruitment Status : Withdrawn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.
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|