Effects of Vitamin D on Inflammation in Liver Disease
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|ClinicalTrials.gov Identifier: NCT01754961|
Recruitment Status : Unknown
Verified December 2012 by Mario Chojkier, Veterans Medical Research Foundation.
Recruitment status was: Recruiting
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Infection Vitamin D Deficiency||Drug: Vitamin D Drug: Placebo||Phase 2|
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by the presence of activated M1 macrophages in liver biopsies from patients with severe drug-induced liver injury (unpublished observations).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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Vitamin D on Inflammation in Liver Disease|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||January 2014|
Placebo Comparator: Placebo
Placebo will be given on Day 1 orally
Placebo given orally on Day 1
Other Name: Emulsion placebo
Active Comparator: Vitamin D
Administration of 500,000 IU Vitamin D orally on Day 1
Drug: Vitamin D
Vitamin D 500,000 IU given orally on Day 1
Other Name: Vitamin D Drug
- Macrophage activation [ Time Frame: one week ]As determined by serum levels and macrophage cytokine production compared to placebo and baseline
- Liver injury [ Time Frame: one week ]Measurement of ALT/AST
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754961
|Contact: Kim Inocencio, BSfirstname.lastname@example.org|
|United States, California|
|UC San Diego, CTRI||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Kim Inocencio, BS 619-717-1906 email@example.com|
|Principal Investigator: Mario Chojkier, MD|
|Principal Investigator:||Mario Chojkier, MD||University of California, San Diego|