Vitamin D Treatment in Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01640496
• Date of registration: 11/07/2012
• Prospective Registration: No
• Primary sponsor: University of Chicago
• Public title: Vitamin D Treatment in Ulcerative Colitis Vitamin D
• Scientific title: Vitamin D Treatment in Ulcerative Colitis
• Date of first enrolment: July 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01640496
• 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
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Joel Pekow, M.D.
• Affiliation: University of Chicago

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Ulcerative Colitis

Intervention(s)

Other: Placebo

Drug: Vitamin D3

Primary Outcome(s)

Mucosal Permeability [Time Frame: 8 weeks]

Secondary Outcome(s)

Mucosal tight junction protein expression [Time Frame: 8 weeks]

Secondary ID(s)

11-0542

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

North Shore University Hospital