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Vitamin D Treatment in Patients With Chronic Hepatitis C

Primary Purpose

Chronic Hepatitis C

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Adding vitamin D
Vitamin D
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Chronic Hepatitis C focused on measuring Patients with Chronic Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic Hepatitis C Genotype 1

Exclusion Criteria:

  • Vitamin D intoxication Renal Failure Liver Failure Malignancy

Sites / Locations

  • Hillel Yaffe Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D

Arm Description

An addition of Vitamin D to the standard treatment

Outcomes

Primary Outcome Measures

To increase the sustained virological response

Secondary Outcome Measures

Full Information

First Posted
December 7, 2008
Last Updated
December 8, 2008
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00804752
Brief Title
Vitamin D Treatment in Patients With Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

5. Study Description

Brief Summary
We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising their vitamin D levels by adding it to their standard treament of Pegylated Interferon and Ribavirin, there will be an increase in their sustained virological response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Patients with Chronic Hepatitis C

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
An addition of Vitamin D to the standard treatment
Intervention Type
Drug
Intervention Name(s)
Adding vitamin D
Intervention Description
Adding 1000IU/Vitamin D daily
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Addition of 1000IU/day Vitamin D
Primary Outcome Measure Information:
Title
To increase the sustained virological response
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Hepatitis C Genotype 1 Exclusion Criteria: Vitamin D intoxication Renal Failure Liver Failure Malignancy
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saif Abu-Mouch, MD
Email
saif@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Saif Abu-Mouch, MD
First Name & Middle Initial & Last Name & Degree
Jacob Yarchovski, MD
First Name & Middle Initial & Last Name & Degree
Carlos Singer, MD
First Name & Middle Initial & Last Name & Degree
Abed El-Rauf Zeina, MD

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Treatment in Patients With Chronic Hepatitis C

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