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

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

IBD is caused by an abnormal immune response to the gut bacteria in people who are genetically predisposed. There has been a huge increase in the number of people diagnosed with IBD since World War II, likely due to changes in our environment. It is possible that the abundance of vitamin D in the body may be one of those environmental factors that the investigators can control to make patients with IBD better.

Vitamin D acts on cells of the immune system and causes many effects, including the production of a "natural antibiotic" called cathelicidin. The investigators know that when people are supplemented with vitamin D, levels of cathelicidin produced by these immune cells increase. By supplementing children with Crohn's disease with vitamin D, the investigators may be able to alter their immune system "naturally," making their disease better. A consensus of vitamin D experts believes that vitamin D levels need to reach a level of 40-70 ng/mL in the blood in order to have effects on the immune system. Raising vitamin D levels to this range is one of the goals in the current study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: The Broad Foundation
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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