Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000897763
Ethics application status
Approved
Date submitted
5/08/2013
Date registered
12/08/2013
Date last updated
7/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of zinc on standard pharmacotherapy hepatitis C treatment
Scientific title
Effect of zinc addition on viral response in hepatitis C and beta thalassemia major patients
Secondary ID [1] 282960 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hepatitis C patients 289786 0
beta thalassemia major 289787 0
Condition category
Condition code
Infection 290138 290138 0 0
Other infectious diseases
Blood 290139 290139 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Addition of oral zinc(30 mg /d elemental) for 48 weeks to standard pharmacotherapy of hepatitis C (peg interferon alfa plus ribavirin) Duration of standard therapy will be 48 weeks too. In other words, peg interferon,ribavirin,zinc/placebo will be start with each other for 48 weeks.
adherence monitoring with tablet return
Intervention code [1] 287671 0
Treatment: Drugs
Comparator / control treatment
placebo ( microcellulose tablet)
Control group
Placebo

Outcomes
Primary outcome [1] 290167 0
Sustained viral response (SVR) with PCR (Polymerase Chain Reaction) method
Definition of SVR:absence of detectable RNA of the hepatitis C virus in plasma for at least 6 months after discontinuing the treatment
Timepoint [1] 290167 0
after 48 weeks all medicine will be discontinue (standard pharmacotherapy with peg interferon plus ribavirin) and zinc/placebo. determination of SVR 6 months after withdrawal of medicines.
Secondary outcome [1] 304038 0
none
Timepoint [1] 304038 0
none

Eligibility
Key inclusion criteria
60 patients with recent diagnosis of chronic hepatitis C and previous diagnosis of beta thalassemia major
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hepatitis B and human immunodeficiency viruses infected, recieving zinc or any complement containing zinc

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2012
Actual
10/07/2012
Date of last participant enrolment
Anticipated
Actual
10/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5264 0
Iran, Islamic Republic Of
State/province [1] 5264 0

Funding & Sponsors
Funding source category [1] 287738 0
University
Name [1] 287738 0
Shahid Beheshti University of Medical Sciences
Country [1] 287738 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Beheshti University of Medical Sciences
Address
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286464 0
None
Name [1] 286464 0
none
Address [1] 286464 0
none
Country [1] 286464 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
In previous studies the addition of zinc to standard therapy of hepatitis C induced limited benefits on viral response and some of these studies have reported improved transaminases with zinc therapy. It is important to notice that a group of the hepatitis C patients have beta thalassemia major as well and combination therapy with INF-a plus ribavirin should be suggested for them . Zinc depletion has been reported in patients with beta thalassemia major under treatment of chelator agents such as deferioxamine, deferiprone and deferasirox. Using of zinc accompanied with standard regimen may have a benefit in pharmacotherapy of chronic hepatitis C with beta thalassemia major.So the aim of present study was to evaluate the effect of zinc administration on viral response in patients with chronic hepatitis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41986 0
Dr Mohammad Abbasinazari
Address 41986 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country 41986 0
Iran, Islamic Republic Of
Phone 41986 0
+98 2188873704
Fax 41986 0
Email 41986 0
[email protected]
Contact person for public queries
Name 41987 0
Dr Mohammad Abbasinazari
Address 41987 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran Shahid Beheshti University of Medical SciencesPO box: 14397-65461
Country 41987 0
Iran, Islamic Republic Of
Phone 41987 0
+98 2188873704
Fax 41987 0
Email 41987 0
[email protected]
Contact person for scientific queries
Name 41988 0
Dr Mohammad Abbasinazari
Address 41988 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country 41988 0
Iran, Islamic Republic Of
Phone 41988 0
+ 98 2188873704
Fax 41988 0
Email 41988 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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