Effects of Vitamin D on Inflammation in Liver Disease
This study is currently recruiting participants.
Verified December 2012 by Veterans Medical Research Foundation
Sponsor:
Veterans Medical Research Foundation
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
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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
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 Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013