Evaluation of L-carnitine medicinal effect in non alcoholic fatty liver
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 100 patients, enrolled between september 2018 and March 2019, and followed for 3 months
Settings and conduct
Patients with non alcoholic fatty liver that refer to Gastrointestinal unit of Isfahan Imam Hossein hospital are divided to intervention and control group . L-carnitine tablet is given to intervention group and placebo is given to control group.
Participants/Inclusion and exclusion criteria
•Inclusion criteria:
1- Children with non alcoholic fatty liver
2- Age 5-15 years old
3-Liver enzyme elevation excess than 40 unit/lit and diagnosis of fatty liver in sonography.
•Exclusion criteria:
1-Viral Hepatitis or auto immune, Diabetes, Hemochromatosis, Cirrhosis, infectious disease, hypothiroidism
2-Consumption of drugs that effect on liver enzyme during last two months
3-Alcohol consumption
4-Discontinuing the study by the patient or his/her family
Intervention groups
Intervention group:5 to 15 years old children with non alcoholic fatty liver who received l-carnitin.
Control group:5 to 15 years old children with non alcoholic fatty liver who received placebo.
Main outcome variables
To obtain an appropriate drug to cure fatty liver in children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170628034786N2
Registration date:2019-01-16, 1397/10/26
Registration timing:registered_while_recruiting
Last update:2019-01-16, 1397/10/26
Update count:0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Majid Khademian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 0350
Email address
m.khademian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of L-carnitine effect in non- alcoholic fatty liver disease (NAFLD) treatment in children
Public title
Evaluation of L-carnitine effect in fatty liver treatment in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with non- alcoholic fatty liver disease
Age between 5-15 years old
Elevation of liver enzyme more than 40 Unit/Litre
Evidence of fatty liver in sonography
Exclusion criteria:
Diagnosis of liver disease other than NAFLD such as : Viral hepatitis,Autoimmune hepatitis,Diabetes,Hemochromatosis,Cirrhosis,Infectious disease,Hypothyroidism
Consumption of drugs that effect on liver enzyme during last two months
Alcohol consumption
Discontinuing the study by the patient or his/her family
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software , patients randomly will allocate to the intervention and control groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this research, patient, researcher, person who gives drug, information collector and data analyzer do not know which patient receive drug and which one receive placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofIsfahan medical university
Street address
Imam Hossein hospital, Imam Khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Approval date
2018-12-17, 1397/09/26
Ethics committee reference number
IR.MUI.MED.REC.1397.171
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Measurement of serum liver specific enzyme level(Alanine aminotransferase)
Timepoint
Three months after treatment initiation with placebo and L-carnitine
Method of measurement
Quantitative measurement of liver transaminase and liver sonography
Secondary outcomes
1
Description
Assaiment of body mass index
Timepoint
Three months after treatment initiation with placebo and L-carnitine
Method of measurement
Measurement of height and weight and ratio of weight to square of height
Intervention groups
1
Description
Control group: Given placebo twice a day for 3 month
Category
Placebo
2
Description
Intervention group: Given Lcarnitine tablet twice a day for 3month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hossein hospital gastrointestinal clinic
Full name of responsible person
majid khademian
Street address
Imam khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 8247
Email
majidkhademian@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid khademian
Street address
Imam khomeini Ave.Imam Hossein hospital
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 8247
Email
m.khademian@med.mui.ac.ir
Grant name
Esfahan University of Medical science
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Majid Khademian
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 8247
Email
majidkhademian@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
majid khademian
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 8247
Email
majidkhademian@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
leila khalilian
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 9141
Email
leilakhalilian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
َAfter the implementation of the research the results will be available to the scientific community.
When the data will become available and for how long
One Year after of publication
To whom data/document is available
Professional Researchers in this field
Under which criteria data/document could be used
After communication with the corresponding author of the project, the researchers in this field can access some statistical analysis file information.
From where data/document is obtainable
Principal Investigator Dr. Majid Khademian
Isfahan University of Medical Sciences, Faculty of Medicine, Pediatric Department of Gastroenterology,
09133711058
m.khademian@med.mui.ac.ir
What processes are involved for a request to access data/document
After E-Mail to the corresponding author of the project, they will be able to provide the documentation to them.