Vitamin D Supplementation in Crohn's Patients

Inflammatory Bowel Disease Clinical Trial

— CTSA  

Official title:

Vitamin D and Crohn's Disease" From the Bench to the Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742781
• Other study ID #: CTSA-PPA-1
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2008
• Last updated: July 8, 2013
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Dietary Supplement:
• Vitamin D
Oral supplementation daily with up to 5000 IU over 6 months.

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crohn's Disease Activity Index	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.	6 months	No
Primary	25(OH)D3 Serum Levels	25(OH)D3 levels before and after vitamin D supplementation.	6 months	No
Secondary	Health Improvement	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.	6 months	No