Objectives
The main objective of this study is to evaluate the impact of addition of vitamin B12 to the standard treatment regimen for hepatitis C genotype one.
Design, setting and conduct
In this study, all patients with chronic hepatitis C genotype 1 referred to hepatitis clinic will be enrolled after obtaining informed consent and exerting exclusion criteria. Patients are randomly assigned to two groups: one with standard therapy and other standard therapy with vitamin B-12. Permuted block randomization will be conducted by an independent personnel. To homogenize two groups randomization will be done based on primary viral levels (higher than IU / ML 600000 or less).
Major exclusion criteria: age <18 or>70 year, HIV or HBV co-infection, concomitant severe disease or any contraindication to interferon and ribavirin taking.
Major inclusion criteria: Patients between 18 and 70 year old, Lack of HIV or HBV co-infection, Lack of concomitant severe disease or any contraindication to interferon and ribavirin taking.
Intervention
Patients in the intervention group will recieve standard regimen with a monthly dose of 5000 micrograms intramuscular vitamin B12 and patients in control group will only take the standard regimen without B12.
Main outcome measures
According to the clinic protocol all routine tests will be done as the standard schedule. At the end of the standard treatment, groups are compared in terms of sustained viral response as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508064226N3
Registration date:2015-09-20, 1394/06/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-20, 1394/06/29
Registrant information
Name
Gholam Reza Sivandzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4316
Email address
ghsivand@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gastroenterohepatology Research Center. Shiraz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin B12 supplementation to the standard therapeutic regimen on sustained viral response in genotype 1 chronic HCV infection
Public title
Vitamin B 12 in the treatment of chronic hepatitis C
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: age <18 or>70 year, previous treatment with interferon and ribavirin, concomitant causes of liver disease, such as hepatitis B virus infection, autoimmunity and alcohol abuse (>40 g/day for men and >20 g/day for women),
HIV infection, hepatocellular carcinoma, decompensated cirrhosis, severe concurrent disease, contraindications to treatment.
Inclusion criteria: age between 18 to70 years, Lack of concomitant causes of liver disease, such as hepatitis B virus infection, autoimmunity and alcohol abuse (>40 g/day for men and >20 g/day for women), Lack of HIV infection, Lack of hepatocellular carcinoma, Lack of decompensated cirrhosis, Lack of severe concurrent disease.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Permuted block randomization will be conducted by an independent personnel.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street, Namazi square,
City
Shiraz
Postal code
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
IR.SUMS.REC.1394.68
Health conditions studied
1
Description of health condition studied
Chronic hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Sustained Virologic Response
Timepoint
6 months after treatment course
Method of measurement
copy of virus in ml of serum
Secondary outcomes
1
Description
Serum viral load
Timepoint
baseline-3months-6months- end of treatment
Method of measurement
Copy of virus per mililiter
2
Description
Liver enzymes
Timepoint
baseline-3months-6months- end of treatment- 6 months after treatment course
Method of measurement
miligram per deciliter of serum
Intervention groups
1
Description
Intervention group: Monthly injection of 1000microgr vitamin b12 produced by Osveh company for 12 months totally.
Category
Treatment - Drugs
2
Description
Control group: Control group will only receive standard treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hepatitis Clinic, Motahari Clinic
Full name of responsible person
Gholam Reza Sivandzadeh
Street address
Motahari Clinic, Namazi square, Zand street,
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Seyyed Basir Hashemi
Street address
Namazi hospital, Namazi square
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gastroenterohepatology research center, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Sivandzadeh
Position
Internal Medicine Ward alumni
Other areas of specialty/work
Street address
Namazi hospital, Namazi hospital, Zand square
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 3236
Fax
Email
ghsivand@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gastroenterohepatology center, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Sivandzadeh
Position
Gastroenterologit, MD
Other areas of specialty/work
Street address
Namazi hospital, Namazi square
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 3236
Fax
Email
ghsivand@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gastroenterohepatology research center
Full name of responsible person
Gholam Reza Sivandzadeh
Position
Internal medicine ward alumni
Other areas of specialty/work
Street address
Namazi hospital, Namazi square, Zand street
City
Shiraz
Postal code
7193711351
Phone
Fax
Email
ghsivand@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)