Comparison of effectiveness of L-carnitine, atorvastatin, L-carnitine+atorvastatin, and placebo on liver enzyme levels and liver stiffness of subjects with nonalcoholic steatohepatitis
This is a double-blind randomized control trial designed to evaluate the effect of atorvastatin and L-carnitine on nonalcoholic steatohepatitis in a 2x2 factorial design. Patients aged between 20 and 60 years referring to a referral center in Tehran will be studied. 440 patients diagnosed as nonalcoholic steatohepatitis will be enrolled. The diagnosis is confirmed by steatosis reported in ultrasonography and elevated liver enzymes. Subjects with other liver disease or severe medical conditions are excluded. Subjects will be randomly assigned to one of four groups: atorvastatin 20 mg daily, L-carnitine 1 gr daily, atorvastatin 20 mg and L-carnitine 1 gr daily, and placebo. Subjects will be followed for 1 year. At the end of the study changes in liver enzyme levels and liver stiffness will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111204092N2
Registration date:2012-02-25, 1390/12/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-02-25, 1390/12/06
Registrant information
Name
Shahin Merat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5300
Email address
merat@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of L-carnitine, atorvastatin, L-carnitine+atorvastatin, and placebo on liver enzyme levels and liver stiffness of subjects with nonalcoholic steatohepatitis
Public title
The effect of atorvastatin and L-carnitine in the treatment of nonalcoholic steatohepatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: ultrasonography showing evidence of hepatic steatosis; increased AST or ALT to above 1.5 times normal; age 20-60 years old.
Exclusion Criteria: hepatitis B; hepatitis C; autoimmune hepatitis; genetic liver disease; alcohol ingestion greater than 40 gr per week; hypertension; diabetes mellitus; liver stiffness more than 7.9 KP; Not consenting to the study.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
440
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Digestive Disease Research Center
Street address
Shariati Hospital
City
Tehran
Postal code
14117
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
416/548
Health conditions studied
1
Description of health condition studied
Nonalcoholic steatohepatitis (NASH)
ICD-10 code
k75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Liver stiffness
Timepoint
years 0 and 1
Method of measurement
FibroScan
2
Description
Liver enzymes (AST and ALT)
Timepoint
months 0, 1, 3, 6, 9, and 12
Method of measurement
Elisa
Secondary outcomes
1
Description
Muscular cramps
Timepoint
months 1, 3, 6, 9, 12
Method of measurement
Questionnaire
2
Description
Nausea
Timepoint
months 1, 3, 6, 9, 12
Method of measurement
Questionnaire
3
Description
Dyspepsia
Timepoint
months 1, 3, 6, 9, 12
Method of measurement
Questionnaire
4
Description
Compliance
Timepoint
months 1, 3, 6, 9, 12
Method of measurement
Questionnaire
Intervention groups
1
Description
Atorvastatin 20 mg daily for 12 months
Category
Treatment - Drugs
2
Description
L-carnitine 1 gr daily for 12 months
Category
Treatment - Drugs
3
Description
Atorvastatin 20 mg and L-carnitine 1 gr daily for 12 months
Category
Treatment - Drugs
4
Description
Placebo daily for 12 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Shahin Merat
Street address
N Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Malekzadeh
Street address
Shariati Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences
Full name of responsible person
Shahin Merat
Position
Associate Professor
Other areas of specialty/work
Street address
Shariati hospital
City
Tehran
Postal code
14117
Phone
+98 21 8241 5111
Fax
+98 21 8241 5400
Email
merat@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Merat
Position
Associate Professor
Other areas of specialty/work
Street address
Shariati hospital
City
Tehran
Postal code
14117
Phone
+98 21 8241 5111
Fax
+98 21 8241 5400
Email
merat@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Merat
Position
Associete Professor
Other areas of specialty/work
Street address
Shariati hospital
City
Tehran
Postal code
14117
Phone
+98 21 8241 5111
Fax
+98 21 8241 5400
Email
merat@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)