Effects of Vitamin D on Inflammation in Liver Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Veterans Medical Research Foundation
Sponsor:
Information provided by (Responsible Party):
Mario Chojkier, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01754961
First received: November 17, 2011
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Hepatitis C Infection
Vitamin D Deficiency
Drug: Vitamin D
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Vitamin D on Inflammation in Liver Disease

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Macrophage activation [ Time Frame: one week ] [ Designated as safety issue: No ]
    As determined by serum levels and macrophage cytokine production compared to placebo and baseline


Secondary Outcome Measures:
  • Liver injury [ Time Frame: one week ] [ Designated as safety issue: Yes ]
    Measurement of ALT/AST


Estimated Enrollment: 24
Study Start Date: November 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo will be given on Day 1 orally
Drug: Placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged 18 or older
  • Total 25-OH Vit D < 25 ng/mL
  • Infection with HCV genotype 1 (subjects infected with multiple genotypes are not eligible).
  • Plasma HCV RNA concentration of >100,000 IU/mL.
  • HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending > 3 months prior to enrollment (including, any IFN-Alpha with or without ribavirin, or other anti-HCV antiviral medication).

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • Patients with Sarcoidosis, Histoplasmosis, Lymphoma, Primary Hyperparathyroidism or Idiophatic Hypercalcemia.
  • Liver Cirrhosis.
  • Known active gastrointestinal disease that could interfere with the absorption of the test article.
  • Laboratory determinations at screening as follows:
  • Hemoglobin <10 g/dL .
  • Serum creatinine that is not within normal limits. However, such subjects may be enrolled if the Cockroft-Gault glomerular filtration rate (GFR) is > 50 mL/minute.
  • Unstable hypertension, cardiac disease or type 2 diabetes requiring changes in treatment with medications 4 weeks prior to screening or during the screening period.
  • Use of an investigational drug within 4 weeks before the screening visit or during the screening period.
  • Use of systemic immunosuppressants (including systemic, oral, or intravenous corticosteroids) or immunomodulating agents within 4 weeks before the screening visit or during the screening period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754961

Contacts
Contact: Kim Inocencio, BS 619-717-1906 kcinocencio@ucsd.edu

Locations
United States, California
UC San Diego, CTRI Recruiting
La Jolla, California, United States, 92093
Contact: Kim Inocencio, BS    619-717-1906    kcinocencio@ucsd.edu   
Principal Investigator: Mario Chojkier, MD         
Sponsors and Collaborators
Veterans Medical Research Foundation
Investigators
Principal Investigator: Mario Chojkier, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Mario Chojkier, Professor of Medicine, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01754961     History of Changes
Other Study ID Numbers: UCSD-111219
Study First Received: November 17, 2011
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Inflammation
Liver Diseases
Vitamin D Deficiency
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014