NCT01754961

Effects of Vitamin D on Inflammation in Liver Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic liver diseases are associated with inflammation. The investigators postulate that Vitamin D may modulate inflammation. Thus the investigators will study the effect of Vitamin D replacement in patients with Hepatitis C infection and Vitamin D deficiency.

Detailed description

Vitamin D appears to be a critical signaling molecule for macrophages because is needed for activation and differentiation of monocytes/macrophages. From our Preliminary Studies( VA Merit Review Grant), we propose that Vitamin D deficiency may alter the 'pro-inflammatory' ('classically activated') M1 macrophages , characterized by i\] high expression of NOS2, TNF-a, IL-1, IL-6, IL-8, TGF-a, CXCL10, and CCL19; and ii\] minimal expression of arginase 1 and mannose R. The clinical relevance of these findings is suggested by the presence of activated M1 macrophages in liver biopsies from patients with severe drug-induced liver injury (unpublished observations). Prospective vitamin D supplementation studies with appropriate endpoints are needed to define the role of vitamin D on inflammation in patients with chronic liver diseases.

Conditions

• Hepatitis C Infection
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Vitamin D	Vitamin D 500,000 IU given orally on Day 1
DRUG	Placebo	Placebo given orally on Day 1

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-10-01
• Completion: 2014-01-01
• First posted: 2012-12-21
• Last updated: 2012-12-21

Locations

1 site across 1 country: United States