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

This study is currently recruiting participants.
Verified February 2013 by University of California, Los Angeles
Sponsor:
Collaborator:
The Broad Foundation
Information provided by (Responsible Party):
David Ziring, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01046773
First received: January 11, 2010
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Vitamin D Deficiency
 Drug: Cholecalciferol
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • The investigators aim to determine the association between vitamin D supplementation and cathelicidin production. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detect changes in Crohn's disease activity: clinically, biochemically, and by surrogate markers. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Children with Crohn's disease less than 35 kg
These are children ages 8 to 18 years inclusive, with mild to moderately active Crohn's disease.
 Drug: Cholecalciferol
Children less than 35 kg will receive 2,000 IU oral cholecalciferol daily for 6 months.
Active Comparator: Children with Crohn's disease 35 kg or greater
These are children ages 8 to 18 years inclusive, with mild to moderately active Crohn's disease.
 Drug: Cholecalciferol
Children 35 kg or greater will receive 4,000 IU oral cholecalciferol daily for 6 months.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046773

Contacts
Contact: David Ziring, MD 3102066134 dziring@mednet.ucla.edu

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: David Ziring, MD     310-206-6134     dziring@mednet.ucla.edu    
Principal Investigator: David Ziring, MD            
Sub-Investigator: Martin Hewison, PhD            
Sponsors and Collaborators
University of California, Los Angeles
The Broad Foundation
Investigators
Principal Investigator: David Ziring, MD University of California, Los Angeles
  More Information

Publications:

Responsible Party: David Ziring, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01046773     History of Changes
Other Study ID Numbers: IBD-0285
Study First Received: January 11, 2010
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Children
Crohn's disease
Vitamin D

Additional relevant MeSH terms:
Crohn Disease
Vitamin D Deficiency
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013