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Vitamin D Supplementation in Crohn's Patients (CTSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742781
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : July 1, 2013
Last Update Posted : July 26, 2013
Information provided by (Responsible Party):
Margherita T. Cantorna, Penn State University

Brief Summary:
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 or disease Intervention/treatment Phase
Inflammatory Bowel Disease Dietary Supplement: Vitamin D Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Vitamin D and Crohn's Disease" From the Bench to the Clinic
Study Start Date : May 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Dietary supplement
Dietary supplement of vitamin D
Dietary Supplement: Vitamin D
Oral supplementation daily with up to 5000 IU over 6 months.
Other Name: Cholecalciferol

Primary Outcome Measures :
  1. Crohn's Disease Activity Index [ Time Frame: 6 months ]
    Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.

  2. 25(OH)D3 Serum Levels [ Time Frame: 6 months ]
    25(OH)D3 levels before and after vitamin D supplementation.

Secondary Outcome Measures :
  1. Health Improvement [ Time Frame: 6 months ]
    International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742781

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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
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Principal Investigator: Margherita T Cantorna, PhD Penn State University

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Responsible Party: Margherita T. Cantorna, Professor, Penn State University Identifier: NCT00742781    
Other Study ID Numbers: CTSA-PPA-1
First Posted: August 28, 2008    Key Record Dates
Results First Posted: July 1, 2013
Last Update Posted: July 26, 2013
Last Verified: July 2013
Keywords provided by Margherita T. Cantorna, Penn State University:
vitamin D
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents