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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
Sponsor:
Information provided by (Responsible Party):
Mario Chojkier, Veterans Medical Research Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Infection Vitamin D Deficiency Drug: Vitamin D Drug: Placebo Phase 2

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by the presence of activated M1 macrophages in liver biopsies from patients with severe drug-induced liver injury (unpublished observations).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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Macrophage activation [ Time Frame: one week ]
    As determined by serum levels and macrophage cytokine production compared to placebo and baseline


Secondary Outcome Measures :
  1. Liver injury [ Time Frame: one week ]
    Measurement of ALT/AST



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


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

Responsible Party: Mario Chojkier, Professor of Medicine, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01754961     History of Changes
Other Study ID Numbers: UCSD-111219
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012

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