The aim of this study was to investigate the effect of l-carnitin administration in the patient with non alcoholic fatty liver disease. In this randomized, double blind trial, eighty patients suffering from fatty liver disease were selected among patients referring to Sheikh Al-Raeis clinic in Tabriz, and assigned into intervention or control group. The patients in both groups were strongly recommended to do exercise and follow a weight loss and low fat diet. The patients in the intervention group received 500mg L carnitin, every 12 hours for 6 months while those in the control group didn’t receive any drug. Main outcome measures are changes in aminotransferase serum level and the grade of fatty liver determined by ultrasonography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102235893N1
Registration date:2011-07-30, 1390/05/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-30, 1390/05/08
Registrant information
Name
Arezo Judaki
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7554
Email address
judakia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-12-31, 1389/10/10
Expected recruitment end date
2011-03-01, 1389/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The L-carnitine effect in the treatment of non alcoholic fatty liver disease
Public title
The L-carnitine effect in non alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: serum level of alanin aminotranspherase and aspartat aminotranspherase more than 40mg, ultrasonograghy evidences of fatty liver
Exclusion criteria: overt diabetes, TG serum over 500mg, other causes of increasing liver enzymes such as viral infections, hemochromatosis , Wilson’s disease, autoimmune diseases, drinking (20 and 10 grams per day for men and women, respectively)
Age
From 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
University Central Building, Golgasht St., Azadi Ave., Tabriz
City
Tabriz
Postal code
5165665811
Approval date
2010-12-30, 1389/10/09
Ethics committee reference number
5/4/7882
Health conditions studied
1
Description of health condition studied
non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Serum level of alanine aminotransferase
Timepoint
Before intervention and six months after initiation of the intervention
Method of measurement
measuring serum level
Secondary outcomes
1
Description
Serum level of aspartate aminotransferase
Timepoint
Before intervention and six months after initiation of the intervention
Method of measurement
by serum level measurement
2
Description
fatty liver grading
Timepoint
befor intervention and six months after initiation intervention
Method of measurement
by ultasonography
Intervention groups
1
Description
IN intervention group: 500mg L- carnitine, two times a day, as well as recommendation for exercise, weight loss and low fat diet, for six months
Category
Treatment - Drugs
2
Description
Contol group: recommendations for exercise, weight loss, and low fat diet for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikh Al-Raeise Clinic
Full name of responsible person
Street address
Corner of Jodeiri Street, Azadi Avenue, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gasrtoenterology Research Centre Of Imam Reza Hospital
Full name of responsible person
Arezo Judaki
Street address
University Street, Imam Reza Hospital, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gasrtoenterology Research Centre Of Imam Reza Hospital
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
Tabriz University of Medical Sciences
Full name of responsible person
Arezo Judaki
Position
Fellowship Of Gasroentrology
Other areas of specialty/work
Street address
Gastroentrology Department, Imam Reza Hospital, University Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1337 4290
Fax
Email
JUDAKIA@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Universitu of Medical Science and Health Services
Full name of responsible person
Seyed Yaaghoob Moaddab
Position
Subspeciality In Gasrology
Other areas of specialty/work
Street address
Imam Reza Hospital, University Street, Tabriz
City
Tabriz
Postal code
Phone
+98 914 361 4684
Fax
Email
ymoaddab@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)