Vitamin D Treatment in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— Vitamin D  

Official title:

Vitamin D Treatment in Ulcerative Colitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01640496
• Other study ID #: 11-0542
• Status: Withdrawn
• Phase: N/A
• First received: July 11, 2012
• Last updated: December 1, 2014
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	NorthShore	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	North Shore University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes