Objective: Evaluation of adding vitamin D to standard HCV regimen(PEG-interferon plus ribaverin) on early virologic response(EVR)
Design: Randomized, not-blinded
Setting and conduct: Sixty patients with untreated chronic hepatitis and positive HCV antibodies, referring to Ghaem and Emam Reza Specialized Clinics, were randomly allocated to 2 groups using stratification method. The groups are as follows:
The intervention group: Thirty patients with hepatitis C, who received the standard treatment based on the PCR results and HCV genotype determination; they were also administered vitamin D.
The control group: Thirty patients with hepatitis C, who received the standard treatment based on the PCR results and HCV genotype determination.
The standard diet in genotype 1 or 4 includes peginterferon α2a (180 mcg) together with (edible) ribavirin (800-1200 mg); the duration of the treatment was 48 weeks.
The standard diet in genotype 2 and 3 includes peginterferon α2a (180 mcg) together with (edible) ribavirin (800 mg), and the treatment takes 24 weeks.
Major criteria to include in the study: The patients with hepatitis C who had not been under therapy were included in the study.
Major criteria to exclude from the study: HIV patients; concurrent infection with hepatitis B and D; alcohol abuse; Wilson’s disease; hemochromatosis; decompensated cirrhosis, child score>9; patients with hepatocellular carcinoma; previous hepatitis C treatment; chronic kidney disorder; using antiepileptic drugs; history of vitamin D consumption (in the control group); pregnancy or breastfeeding; and steroid consumption.
Intervention: D vitamin, Weekly, 1600 Unit a day, for 8 to 12 weeks. Then monthly to the end of treatment.
Primary outcome measure: D Vitamin and Calcium serum level, At the beginning of treatment and every three months to the end of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112915581N1
Registration date:2013-12-25, 1392/10/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-12-25, 1392/10/04
Registrant information
Name
Ladan Goshayeshi
Name of organization / entity
Emam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 1763 0105
Email address
goshayeshil911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adding vitamin D to standard HCV regimen(PEG-interferon plus ribaverin) on early virologic response(EVR)
Public title
Dietary supplement in chronic hepatitis C treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Major criteria to include in the study: The patients with hepatitis C who had not been under therapy were included in the study.
Major criteria to exclude from the study: HIV patients; concurrent infection with hepatitis B and D; alcohol abuse; Wilson’s disease; hemochromatosis; decompensated cirrhosis, child score>9; patients with hepatocellular carcinoma; previous hepatitis C treatment; chronic kidney disorder; using antiepileptic drugs; history of vitamin D consumption (in the control group); pregnancy or breastfeeding; and steroid consumption.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Danehgah Street, Ghoreishi Building, Mashhad
City
Mashhad
Postal code
91375-3316
Approval date
2013-08-16, 1392/05/25
Ethics committee reference number
911015
Health conditions studied
1
Description of health condition studied
Hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
D Vitamin serum level
Timepoint
At the beginning of treatment and every three months to the end of treatment
Method of measurement
Blood Sampling
2
Description
Calcium serum level
Timepoint
At the beginning of treatment and every three months to the end of treatment
Method of measurement
Blood Sampling
Secondary outcomes
1
Description
Quantification of HCV RNA
Timepoint
At weeks 4 and 12 during the treatment period for the assessment of RVR and EVR and at the end of treatment and 24 weeks after
Method of measurement
By Quantitative PCR
Intervention groups
1
Description
Intervention group: D vitamin, Weekly,
1600 Unit a day, for 8 to 12 weeks. Then monthly to the end of treatment.
Category
Treatment - Drugs
2
Description
Control group: Standard diet, The standard diet in genotype 1 or 4 includes peginterferon α2a (180 mCg) together with (edible) ribavirin (800-1200 mg), the duration of the treatment is 48 weeks.
The standard diet in genotype 2 and 3 includes peginterferon α2a (180 mCg) together with (edible) ribavirin (800 mg), and the treatment takes 24 weeks.