Back to resultsEffects of Vitamin D on Inflammation in Liver Disease
Primary Purpose
Hepatitis C Infection, Vitamin D Deficiency
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Infection
Eligibility 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.
Sites / Locations
- UC San Diego, CTRIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Vitamin D
Arm Description
Placebo will be given on Day 1 orally
Administration of 500,000 IU Vitamin D orally on Day 1
Outcomes
Primary Outcome Measures
Macrophage activation
As determined by serum levels and macrophage cytokine production compared to placebo and baseline
Secondary Outcome Measures
Liver injury
Measurement of ALT/AST
Full Information
NCT ID
NCT01754961
First Posted
November 17, 2011
Last Updated
December 18, 2012
Sponsor
Veterans Medical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01754961
Brief Title
Effects of Vitamin D on Inflammation in Liver Disease
Official Title
Effects of Vitamin D on Inflammation in Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Infection, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be given on Day 1 orally
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Administration of 500,000 IU Vitamin D orally on Day 1
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Vitamin D Drug
Intervention Description
Vitamin D 500,000 IU given orally on Day 1
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Emulsion placebo
Intervention Description
Placebo given orally on Day 1
Primary Outcome Measure Information:
Title
Macrophage activation
Description
As determined by serum levels and macrophage cytokine production compared to placebo and baseline
Time Frame
one week
Secondary Outcome Measure Information:
Title
Liver injury
Description
Measurement of ALT/AST
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Inocencio, BS
Phone
619-717-1906
Email
kcinocencio@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Chojkier, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego, CTRI
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Inocencio, BS
Phone
619-717-1906
Email
kcinocencio@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Mario Chojkier, MD
12. IPD Sharing Statement
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Effects of Vitamin D on Inflammation in Liver Disease
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