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

Stopped early · Phase 1

Conditions studied: Crohn's Disease, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT01046773

Run by

University of California, Los Angeles

People needed

3

Starts

2010-01-01

Expected to finish

2017-05-01

Last updated by the study team

2018-02-07

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of mild to moderate Crohn's disease
• 8 to 18 years old, inclusive

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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