Vitamin D Deficiency Clinical Trial
Official title:
Effects of Vitamin D on Inflammation in Liver Disease
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | January 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UC San Diego, CTRI | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Veterans Medical Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Macrophage activation | As determined by serum levels and macrophage cytokine production compared to placebo and baseline | one week | No |
Secondary | Liver injury | Measurement of ALT/AST | one week | Yes |
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