Ignite Creation Date:
2025-12-17 @ 10:12 PM
Ignite Modification Date:
2025-12-23 @ 5:41 PM
Study NCT ID:
NCT00742781
Status:
None
Last Update Posted:
2013-07-26 00:00:00
First Post:
2008-08-26 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in Crohn's Patients
Sponsor:
None
Organization:
Study Overview
Official Title:
Vitamin D and Crohn's Disease" From the Bench to the Clinic
Status:
None
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTSA
Brief Summary:
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: