Lay Summary
Proposal No. IBD-0285
Principal Investigator: David Ziring, M.D.
Applicant Organization: University of California, Los Angeles (U.S.A.)
Project Title: Vitamin D supplementation as non-toxic immunomodulation in children with Crohn’s disease
Period of Award: January 1, 2010 – December 31, 2012
This study is a pilot project done in order to validate and refine a hypothesis so that a larger multicenter trial can be performed to evaluate the use of vitamin D as a therapeutic agent in a larger cohort of pediatric patients. Bigger study populations are needed to evaluate measures such as the efficacy of vitamin D in maintaining Crohn’s disease remission, because the statistical differences we measure when comparing drug to placebo are only detectable when looking at its effects in lots of patients.
Many patients with inflammatory bowel disease (IBD) are deficient in levels of vitamin D in their bodies. But while much attention has been given to studying the impact of vitamin D deficiency on the bone status of patients with IBD, our understanding of how vitamin D deficiency might affect the immune system in these patients is relatively poor.
Vitamin D acts on cells of the immune system and causes many effects, including the production of a “natural antibiotic” called cathelicidin. We know that when people are supplemented with vitamin D, levels of cathelicidin produced by these immune cells increase. We believe that by supplementing children with Crohn’s disease with vitamin D, we 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.
This study is a pilot project done in order to validate and refine a hypothesis so that a larger multicenter trial can be performed to evaluate the use of vitamin D as a therapeutic agent in a larger cohort of pediatric patients. Bigger study populations are needed to evaluate measures such as the efficacy of vitamin D in maintaining Crohn’s disease remission, because the statistical differences we measure when comparing drug to placebo are only detectable when looking at its effects in lots of patients.