Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
24 participants
INTERVENTIONAL
2011-11-30
2014-01-31
Brief Summary
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Detailed Description
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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by the presence of activated M1 macrophages in liver biopsies from patients with severe drug-induced liver injury (unpublished observations).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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo will be given on Day 1 orally
Placebo
Placebo given orally on Day 1
Vitamin D
Administration of 500,000 IU Vitamin D orally on Day 1
Vitamin D
Vitamin D 500,000 IU given orally on Day 1
Interventions
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Vitamin D
Vitamin D 500,000 IU given orally on Day 1
Placebo
Placebo given orally on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Veterans Medical Research Foundation
OTHER
Responsible Party
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Mario Chojkier
Professor of Medicine
Principal Investigators
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Mario Chojkier, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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UC San Diego, CTRI
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Kim Inocencio, BS
Role: primary
Other Identifiers
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UCSD-111219
Identifier Type: -
Identifier Source: org_study_id