Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 8 - 18 |
| Updated: | 2/9/2018 |
| Start Date: | January 2010 |
| End Date: | May 2017 |
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.
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.
Vitamin D is an important nutrient controlling the health and development of our bones. Many
patients with inflammatory bowel disease (IBD) are deficient in levels of vitamin D in their
bodies. This is probably because vitamin D is lost from inflamed intestinal tissue into the
stools. 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.
The investigators intend to study vitamin D supplementation in children with Crohn's disease,
ages 8 to 18 years. At the time of enrollment, the investigators will gather data on disease
activity using both a simple history and physical exam, as well as blood and stool tests. In
addition, the investigators will measure the levels of cathelicidin produced by the immune
cells in their blood. The investigators will then supplement 20 children with vitamin D for a
total of 6 months. During the study, patients will be seen every two months, where the
investigators will monitor their vitamin D levels as well as perform rigorous safety
monitoring for toxicity using blood and urine tests.
And at study conclusion, the investigators will again judge their disease severity and check
their vitamin D levels in addition to tests of cathelicidin levels. The investigators believe
that at study conclusion, the investigators will have achieved several important objectives.
First, as a public health benefit, the investigators will show that large doses of
supplemental vitamin D are safe in children and provide more benefit with less risk. Our
patients will achieve those levels of vitamin D agreed by expert opinion that are required to
cause effects on the immune system, and the investigators will see an increase in the amount
of cathelicidin produced by their immune cells. As an added piece of information, the
investigators would like to determine if there are any improvements in disease activity in
patients supplemented with vitamin D.
patients with inflammatory bowel disease (IBD) are deficient in levels of vitamin D in their
bodies. This is probably because vitamin D is lost from inflamed intestinal tissue into the
stools. 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.
The investigators intend to study vitamin D supplementation in children with Crohn's disease,
ages 8 to 18 years. At the time of enrollment, the investigators will gather data on disease
activity using both a simple history and physical exam, as well as blood and stool tests. In
addition, the investigators will measure the levels of cathelicidin produced by the immune
cells in their blood. The investigators will then supplement 20 children with vitamin D for a
total of 6 months. During the study, patients will be seen every two months, where the
investigators will monitor their vitamin D levels as well as perform rigorous safety
monitoring for toxicity using blood and urine tests.
And at study conclusion, the investigators will again judge their disease severity and check
their vitamin D levels in addition to tests of cathelicidin levels. The investigators believe
that at study conclusion, the investigators will have achieved several important objectives.
First, as a public health benefit, the investigators will show that large doses of
supplemental vitamin D are safe in children and provide more benefit with less risk. Our
patients will achieve those levels of vitamin D agreed by expert opinion that are required to
cause effects on the immune system, and the investigators will see an increase in the amount
of cathelicidin produced by their immune cells. As an added piece of information, the
investigators would like to determine if there are any improvements in disease activity in
patients supplemented with vitamin D.
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
We found this trial at
1
site
Los Angeles, California 90095
310-825-4321
Principal Investigator: David Ziring, MD
Phone: 310-206-6134
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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