Comparison between efficacy and adverse effects of Ursodeoxy cholic acid, silymarin and vitamin E and placebo (Folic acid) in Anticonvulsive drugs induced hypertransaminasemia in 4 months to 13 years old patients
This study is a residency thesis and a randomized placebo-controlled trial. The aim of it is evaluation of efficacy of hepatoprotective drugs including Ursodeoxy cholic acid, Silymarin and Vitamin E in drug induced hepatitis and comparison of them and with placebo.Every patient with significant hypertransaminasemia (rise of transaminases behind the twice of upper normal limits) after rule out of common and important causes of hepatitis such as viral, autoimmune and metabolic diseases and after rule out of anatomic abnormalities was recruited in study.Any patient with other possible causes of hypertransaminasemia and without parents consent or with transient course(less than 2 months hypertransaminasemia) was excluded.100 patients aged 4mo-13yr with persistent hypertransaminasemia from pediatric neurology clinic of Valiasr Hospital after rule out of other etiologies were randomized based on block randomization method to 4 parallel groups and allocated to receive Ursodeoxy cholic acid in dose of 10mg/kg/day or Silymarin in dose of 5mg/kg/day or Vitamin E in dose of 1mg(IU)/kg/day up to 50 mg or Folic acid 1mg/day as placebo for one month. All parents gave consent.Transaminases were checked before and one month after intervention and one month after cessation of it and their levels were compared between groups and in each group as before and after variables.None of our patients showed hepatic functional defects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010711392N2
Registration date:2015-02-02, 1393/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-02, 1393/11/13
Registrant information
Name
Masoumeh Asgarshirazi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1596
Email address
m_shirazi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between efficacy and adverse effects of Ursodeoxy cholic acid, silymarin and vitamin E and placebo (Folic acid) in Anticonvulsive drugs induced hypertransaminasemia in 4 months to 13 years old patients
Public title
Comparison between Ursodeoxy cholic acid, silymarin and vitamin E in Anticonvulsive drugs induced hypertransaminasemia
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with age between 4 months to 13 years in pediatric neurology ward and clinic of Valiasr hospital with anticonvulsive induced hypertransaminasemia after rule out of common causes of hepatitis such as viral, autoimmune, metabolic and after rule out of anatomical defects have been included. Any patient without parents consent was excluded and any patient with spontaneous decline in transaminases were excluded too.
Age
From 4 months old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of Tehran University of Medical Sciences
Street address
Poursina street, Keshavarz Blvd.,Tehran
City
Tehran
Postal code
141761351
Approval date
2012-06-20, 1391/03/31
Ethics committee reference number
1391-1075
Health conditions studied
1
Description of health condition studied
drug induced hypertransaminasemia
ICD-10 code
R74.0
ICD-10 code description
abnormal serum enzyme levels
Primary outcomes
1
Description
Transaminases levels
Timepoint
one month after intervention and one month after cessation of it
Method of measurement
serum transaminases with one standard kit and in International Unite per litre
Secondary outcomes
1
Description
No rebound elevation of serum transaminases after cessation of intervention
Timepoint
one month after intervention cessation
Method of measurement
with standard lab kit and in International Unite per litre
Intervention groups
1
Description
prescription of Folic acid as placebo in dose of 1mg/day in drug-induced hypertransaminasemia
Category
Treatment - Drugs
2
Description
prescription of Ursodeoxy cholic acid in dose of 10mg/kg/day in drug induced hypertransaminasemia
Category
Treatment - Drugs
3
Description
prescription of Silymarin in dose of 5mg/kg/day for anticonvulsive induced hypertransaminasemia
Category
Treatment - Drugs
4
Description
prescription of Vitamin E in dose of 1mg or IU/kg/day up to 50mg/day for drug induced hypertransaminasemia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric neurology ward and clinic of Valiasr Hospital, Imam Khomeini Hospital complex
Full name of responsible person
Masoumeh Asgarshirazi
Street address
Pediatrics ward, Valiasr Hospital, Imam Khomeini Hospital complex-Keshavarz Blvd- Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research-Medical school of Tehran University of Medical Sciences
Full name of responsible person
Dr.Shahin Akhondzade
Street address
Poursina street, Keshavarz Blvd.,Tehran
City
Tehran
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-Medical school of Tehran 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
School of Medicine,Tehran University of Medical Sciences