Effect of treatment with L-Carnitin versus no treatment on the stage of disease in patients with nonalcoholic fatty liver: a single blind randomized clinical trial
Objectives: To assess the effect of treatment with L-Carnitin versus no treatment on the stage of disease in patients with nonalcoholic fatty liver.
Design: a single blind randomized clinical trial.
Setting and conduct: The eligible patients who with nonalcoholic fatty liver refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Affected with nonalcoholic fatty liver.
Exclusion criteria: Using methotrexate medication; viral hepatitis; hyperthyroidisms; hypothyroidisms; uncontrolled diabetes.
Intervention group: Routine treatment plus oral L-Carnitin 1 gr per day for 6 months.
Control group: Just routine treatment.
Primary outcome: Assessing the stage of disease before and 6 months after treatment using liver sonography.
Secondary outcome: Assessing liver enzymes before and 6 months after treatment using laboratory tests.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610069014N121
Registration date:2016-10-08, 1395/07/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-08, 1395/07/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of treatment with L-Carnitin versus no treatment on the stage of disease in patients with nonalcoholic fatty liver: a single blind randomized clinical trial
Public title
Effect of treatment with L-Carnitin versus no treatment on the stage of disease in patients with nonalcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Affected with nonalcoholic fatty liver.
Exclusion criteria: Using methotrexate medication; viral hepatitis; hyperthyroidisms; hypothyroidisms; uncontrolled diabetes.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-08-06, 1395/05/16
Ethics committee reference number
IR.UMSHA.REC.1395.254
Health conditions studied
1
Description of health condition studied
nonalcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Assessing the stage of disease
Timepoint
before and 6 months after treatment
Method of measurement
using liver sonography
Secondary outcomes
1
Description
Assessing liver enzymes
Timepoint
before and 6 months after treatment
Method of measurement
using laboratory tests
Intervention groups
1
Description
Routine treatment plus oral L-Carnitin 1 gr per day for 6 months
Category
Treatment - Drugs
2
Description
Just routine treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Saed Karimdadi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Shahid Beheshti Hospital
Full name of responsible person
Saed Karimdadi
Position
Medical Student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
saedkid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Mayam Hassan Zarini
Position
Internist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
Mhzarrini@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)