Vitamin D Supplementation in Crohn's Patients (CTSA)
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.
|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|
- 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.
- 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.
|Study Start Date:||May 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742781
|United States, Pennsylvania|
|Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Pennsylvania State University|
|University Park, Pennsylvania, United States, 16802|
|Principal Investigator:||Margherita T Cantorna, PhD||Penn State University|