Trial record 8 of 217 for:    Open Studies | "Colitis"

Vitamin D Treatment in Ulcerative Colitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by University of Chicago
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014