Effects of Vitamin D on Inflammation in Liver Disease

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C Infection, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT01754961

Run by

Veterans Medical Research Foundation

People needed

24

Starts

2011-11-01

Expected to finish

2014-01-01

Last updated by the study team

2012-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• UC San Diego, CTRI — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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