Vitamin D Supplementation in Crohn's Patients (CTSA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Margherita T. Cantorna, Penn State University
ClinicalTrials.gov Identifier:
NCT00742781
First received: August 26, 2008
Last updated: July 8, 2013
Last verified: July 2013
  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:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Crohn's Disease Activity Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • 25(OH)D3 Serum Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    25(OH)D3 levels before and after vitamin D supplementation.


Secondary Outcome Measures:
  • Health Improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: May 2009
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Professor, Penn State University
ClinicalTrials.gov Identifier: NCT00742781     History of Changes
Other Study ID Numbers: CTSA-PPA-1
Study First Received: August 26, 2008
Results First Received: January 23, 2013
Last Updated: July 8, 2013
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 August 26, 2014