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Vitamin D Supplementation in Crohn's Patients (CTSA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Penn State University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00742781
First received: August 26, 2008
Last updated: May 25, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of this study is to determine the effect of vitamin D supplementation in Crohn's disease patients. Patients will be evaluated for increases in circulating vitamin D levels and effects on health benefits including improved bone markers, Crohn's disease activity scores, and inflammatory markers.


Condition Intervention Phase
Inflammatory Bowel Disease
 Dietary Supplement: Vitamin D
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Vitamin D and Crohn's Disease" From the Bench to the Clinic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Crohn's disease activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health improvement (questionaire) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • bone mineral density [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 25(OH)D3 improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Vitamin D
    Oral supplementation daily with up to 5000 IU over 6 months.
    Other Name: Cholecalciferol
Detailed Description:

The incidence of autoimmune diseases like inflammatory bowel disease (IBD) has increased in developed countries over the last 50 years. We propose that decreased outdoor activity and increased pollution and diets that lack adequate vitamin D have combined to create large fluctuations in vitamin D status in developed countries and especially in populations that experience winter. Experimentally we've shown that changes in vitamin D status results in more severe forms of experimental IBD. In addition, active vitamin D (1,25(OH)2D3) completely blocks the development of experimental IBD. The vitamin D hypothesis proposes that vitamin D regulates the development and function of the immune system and that changes in vitamin D status affect the development of the resultant immune response and the development of diseases like IBD. Our hypothesis is that because of low dietary vitamin D intakes and malabsorption of many nutrients, Crohn's patients will have low circulating vitamin D levels that are detrimental for their health. We plan to give Crohn's patients 1000 IU of vitamin D/d and determine whether this dose is well tolerated, induces an increase in circulating vitamin D levels and has any additional health benefits (improved bone markers, Crohn's disease activity scores, inflammatory markers).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18-70 years of age with mild to moderate Crohn's disease who are not on active steroid treatment and who do not have ostomies.

Exclusion Criteria:

  • Patients with ulcerative colitis or other bowel conditions which are not Crohn's.
  • Patients with ostomies.
  • Those currently using supplemental vitamin D in excess of the amount in one multivitamin per day.
  • Regular tanning bed users.
  • Persons who report more than moderate alcohol consumption ( > 1 drink/day for women > 2 for men).
  • Pregnant or lactating women or women planning a pregnancy during the study time frame.
  • Regular users of medications which may interfere with assessment of study outcomes .
  • Those who cannot understand written or spoken English .
  • Individuals under medical psychiatric care.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742781

Locations
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Margherita T Cantorna, PhD Penn State University
  More Information

No publications provided

Responsible Party: Margherita T. Cantorna, Penn State University
ClinicalTrials.gov Identifier: NCT00742781     History of Changes
Other Study ID Numbers: CTSA-PPA-1
Study First Received: August 26, 2008
Last Updated: May 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Crohn's
vitamin D

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
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 19, 2013