Vitamin D Treatment in Ulcerative Colitis
This study is not yet open for participant recruitment.
Verified July 2012 by University of Chicago
Sponsor:
University of Chicago
Collaborator:
North Shore University Hospital
Information provided by (Responsible Party):
Joel Pekow, University of Chicago
ClinicalTrials.gov Identifier:
NCT01640496
First received: July 11, 2012
Last updated: July 16, 2012
Last verified: July 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Ulcerative Colitis Inflammatory Bowel Disease |
Drug: Vitamin D3 Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vitamin D Treatment in Ulcerative Colitis |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Mucosal Permeability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: 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.
Other Name: Placebo
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640496
Contacts
| Contact: Joel Pekow, M.D. | 773-834-8632 | jpekow@medicine.bsd.uchicago.edu |
| Contact: Joel Pekow, M.D | 773-834-8632 | jpekow@medicine.bsd.uchicago.edu |
Locations
| United States, Illinois | |
| NorthShore | Not yet recruiting |
| Evanston, Illinois, United States, 60201 | |
| Principal Investigator: Eugene Yen, M.D. | |
Sponsors and Collaborators
University of Chicago
North Shore University Hospital
Investigators
| Principal Investigator: | Joel Pekow, M.D. | University of Chicago |
More Information
No publications provided
| Responsible Party: | Joel Pekow, Assistant Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01640496 History of Changes |
| Other Study ID Numbers: | 11-0542 |
| Study First Received: | July 11, 2012 |
| Last Updated: | July 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Ulcerative Colitis Inflammatory Bowel disease IBD Vitamin D |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Inflammatory Bowel Diseases Intestinal Diseases Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |
Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 21, 2013