Effects of Vitamin D on Inflammation in Liver Disease

• Status: Unknown status
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veterans Medical Research Foundation
• Treatments: Ergocalciferols; Vitamin D; Vitamins

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.