Vitamin D Treatment in Ulcerative Colitis

NCT01640496 | Withdrawn

• 1 other identifier: 11-0542
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ulcerative Colitis; Inflammatory Bowel Disease

Keywords

Ulcerative Colitis; Inflammatory Bowel disease; IBD; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Mucosal tight junction protein expression

  8 weeks

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Subjects will take 1 pill per day for 8 weeks.

Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR

Subjects will be asked to take 1 pill per day for 8 weeks.

Other: Placebo

Interventions

Vitamin D3 DRUG

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.

Also known as: Cholecalciferol

Vitamin D

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• North Shore University Hospital: collaborator

Study Sites (1)

NorthShore

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Joel Pekow, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)