Recruiting
Phase 2

Vitamin D

Sponsor:

Veterans Medical Research Foundation

Code:

NCT01754961

Conditions

Hepatitis C Infection

Vitamin D Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin D

Placebo

Study Details

Brief 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.

Conditions

Hepatitis C Infection

Vitamin D Deficiency

Study ID

NCT01754961

Start date

Nov, 2011

Status verified date

Dec, 2012

Completion date

Jan, 2014

Anticipated

Primary completion date

Oct, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo will be given on Day 1 orally

active comparator: Vitamin D

Administration of 500,000 IU Vitamin D orally on Day 1

Interventions

Vitamin D

Vitamin D 500,000 IU given orally on Day 1

Placebo

Placebo given orally on Day 1

Primary outcome measure

  • Macrophage activation [ Time Frame: one week ]

Central Contacts and Locations

Central contacts

Kim Inocencio, BS

619-717-1906kcinocencio@ucsd.edu

Locations

UC San Diego, CTRI

Recruiting

La Jolla, California, United States, 92093

Contacts

Kim Inocencio, BS

619-717-1906kcinocencio@ucsd.edu

Principal Investigator:

Mario Chojkier, MD

More Information

Sponsor

Veterans Medical Research Foundation

Last update posted

Dec 21, 2012

Last verified

Dec, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Veterans Medical Research Foundation on 2012-12-21.