Comparison and examination of the effect of vitamin E on the improvement of hepatic indexes in patients with acute hepatitis A
Design
100 patients with hepatitis A attending in Imam Khomeini hospital, Zabol, will be allocated to intervention (vitamin E) and control using random number table. Allocation will be performed as simple random sampling.
Settings and conduct
A checklist will be completed for each patient attending in Imam Khomeini clinic in Zabol including demographic, clinical anthropometric and biochemical characteristics. These information will be provided from patients or their parents or their files. Liver enzymes including Aspartate Aminotransferase and Alanine aminotransferase measured in the laboratory of Imam Khomeini hospital, Zabol using autoanalyzer
Participants/Inclusion and exclusion criteria
Inclusion criteria:Having Coagulopathy (<PT INR), Encephalopathy,Intolerance po, Anti-HAV positive.
Exclusion criteria: HAV positive for up to 6 months, Having a abdominal pain, changing the color of the urine, changing the color of the stool, jaundice. Taking any medication
Intervention groups
Patients will be referred to the physician after allocating into control (100 patients) and intervention (100 patients) groups. The intervention group including patients with hepatitis A will receive vitamin E (400 mg single dose per day) after primary examination by the physician. Control group including patients with hepatitis A receiving no drug.
Main outcome variables
Measurment of liver enzymes including aspartate aminitransferase and Alanine aminotransferase.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171205037752N1
Registration date:2018-02-01, 1396/11/12
Registration timing:retrospective
Last update:2018-02-01, 1396/11/12
Update count:0
Registration date
2018-02-01, 1396/11/12
Registrant information
Name
Elahe Bahmadisani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 2183
Email address
sanipharmacy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2017-10-02, 1396/07/10
Actual recruitment start date
2016-10-01, 1395/07/10
Actual recruitment end date
2017-08-01, 1396/05/10
Trial completion date
empty
Scientific title
Comparison and examination of the effect of vitamin E on the improvement of hepatic indexes in patients with acute hepatitis A
Public title
Evaluation of the improvement effects of Vitamin E on liver indexs in pationts with acute hepatitis A
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Coagulopathy (<PT INR)
Encephalopathy
intolerance po
Anti HAV positive
Exclusion criteria:
HAV positive for up to 6 months
Having a abdominal pain
Change the color of the urine
Change the stool color
jaundice
Taking any medication
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
200
Actual sample size reached:
155
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple randomization. The randomization unit is individual and the randomization tool is random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The medicine is prescribed by the doctor, but this study is being reviewed by another investigator.Therefore, the investigator can not diagnose the patient who received the medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Zabol University of Medical Sciences
Street address
Shahid Rajaee St., Educational Complex of Zabol University of Medical Sciences
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
Zbmu.1.REC.1396.63
Health conditions studied
1
Description of health condition studied
Hepatitis A acute
ICD-10 code
B15
ICD-10 code description
Acute hepatitis A
Primary outcomes
1
Description
Measurement of liver enzyme alanine aminotransferase
Timepoint
Measuring liver enzyme including Alanine aminotransferase before the intervention and two weeks, one, two, three, four and six months after prescribing vitamin E.
Method of measurement
In the laboratory by an auto-analyzer
2
Description
Measuring the aspartate aminotransferase Liver Enzyme
Timepoint
Measuring liver enzyme including aspartate aminitransferase before the intervention and two weeks, one, two, three, four and six months after prescribing vitamin E.
Method of measurement
In the laboratory by an auto-analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin E pearls (Alpha-Tocopherol) with chemical formula as of C29H50O2 , 400 mg per day for six months.
Category
Treatment - Drugs
2
Description
Control group: Not receiving any treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Khomeini Hospital in Zabol
Full name of responsible person
Elahe Bahmadisani
Street address
Imam Khomeini Specialized Clinic, In front of the Central Building of Zabol University of Medical Sciences, Jahad Square, Zabol, Iran.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861673137
Phone
+98 54 3222 6069
Email
sanipharmacy91@gmail.com
Web page address
http://www.zbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Kaveh Tabrizian
Street address
Shahid Rajaee St., Educational Complex of Zabol University of Medical Sciences
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3225 4700
Email
K-Tabrizian2005@yahoo.com
Web page address
http://www.zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Elahe Bahmadisani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Rajaee St., Educational Complex of Zabol University of Medical Sciences
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3223 2183
Email
sanipharmacy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Iraj Shahramian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Rajaee St., Educational Complex, Zabol University of Medical Sciences
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3225 4700
Email
Ir_Buper@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Elahe Bahmadisani
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Rajaee St., Educational Complex of Zabol University of Medical Sciences
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3223 2183
Email
sanipharmacy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of ethical issues and the confidentiality of information