Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01046773
• Date of registration: 11/01/2010
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease
• Scientific title: Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease
• Date of first enrolment: January 2010
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01046773
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: David Ziring, MD
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of mild to moderate Crohn's disease

- 8 to 18 years old, inclusive

Exclusion Criteria:

- Children less than 8 years or greater than 18 years at the time of study screening

- Patients with a documented history of hypercalcemia, renal insufficiency, or
nephrolithiasis

- Patients taking cholestyramine

- Patients who have a GI tract in discontinuity (ostomy)

- Patients who have serum 25-OH vitamin D levels of >50 ng/mL at the time of study
screening



Age minimum: 8 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Vitamin D Deficiency

Intervention(s)

Drug: Cholecalciferol

Primary Outcome(s)

The investigators aim to determine the association between vitamin D supplementation and cathelicidin production. [Time Frame: 6 months]

The investigators aim to achieve patient target serum levels of 25-hydroxy vitamin D between 40-60 ng/mL after 6 months of supplementation [Time Frame: 6 months]

Secondary Outcome(s)

Detect changes in Crohn's disease activity: clinically, biochemically, and by surrogate markers. [Time Frame: 6 months]

Secondary ID(s)

IBD-0285

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Broad Foundation