NCT01754961

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

1.9 years

First QC Date

November 17, 2011

Last Update Submit

December 18, 2012

Conditions

Hepatitis C InfectionVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Macrophage activation

    As determined by serum levels and macrophage cytokine production compared to placebo and baseline

    one week

Secondary Outcomes (1)

  • Liver injury

    one week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be given on Day 1 orally

Drug: Placebo

Vitamin D

ACTIVE COMPARATOR

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

Drug: Vitamin D

Interventions

Vitamin DDRUG

Vitamin D 500,000 IU given orally on Day 1

Also known as: Vitamin D Drug
Vitamin D
PlaceboDRUG

Placebo given orally on Day 1

Also known as: Emulsion placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego, CTRI

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis CVitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Mario Chojkier, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Inocencio, BS

CONTACT

619-717-1906kcinocencio@ucsd.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 17, 2011

First Posted

December 21, 2012

Study Start

November 1, 2011

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations

US(1)