The main aim of this study is to investigate the effect of metformin and vitamin E on echogenisity of liver in obese children with fatty liver. 104 patients (4-18 years old) with fatty liver are recruited and randomly assigned into four equal number groups to receive metformin 500 mg bd, metformin 500 mg tds, vitamin E 400 u or vitamin E 800 u for two months. Liver sonography is performed in all patients. If the patient was not cured, we continue the intervention for two month and repeat liver sonography and changes are compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021012421N1
Registration date:2013-05-05, 1392/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-05, 1392/02/15
Registrant information
Name
Kobra Shiasi arani
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5557 4430
Email address
shiasi_k@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of vitamin E and metformin on fatty liver in obese children
Public title
The effect of vitamin E and metformin on fat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: presence of fatty liver. Exclusion criteria: alcoholism; another chronic disease such as viral hepatitis.
Age
From 4 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences and Health Services
Street address
Medical college, Ghotb Ravandi boulevard
City
Kashan
Postal code
8715981151
Approval date
2012-03-13, 1390/12/23
Ethics committee reference number
4269/1529/پ
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
liver ecogenicity
Timepoint
before and 2 months after the intervention and end of intervention (four months after intervention)
Method of measurement
sonography
Secondary outcomes
1
Description
BMI
Timepoint
before and 2 months after the intervention and end of intervention (four months after intervention)
Method of measurement
balance and height messuring instruments
Intervention groups
1
Description
Metformin 500mg tab bd
Category
Treatment - Drugs
2
Description
Metformin 500mg tab tds
Category
Treatment - Drugs
3
Description
vitamin E 400 unit pearl daily
Category
Treatment - Drugs
4
Description
vitamin E 400 unit pearl bd
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Kashan University of Medical Sciences and Health Services
Full name of responsible person
Moazami Goudarzi Raziyeh
Street address
Medical college, Ghotb Ravandi boulevard
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr. Qolam Ali Hamidi
Street address
Medical college, Ghotb Ravandi boulevard
City
Kashan
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, Kashan University of Medical Sciences and Health Services
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Moazami Goudarzi Raziyeh
Position
resident of pediatrics medicine
Other areas of specialty/work
Street address
Medical college, Ghotb Ravandi boulevard
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
dr.goudaezi1984@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Moazami Goudarzi Raziyeh
Position
resident of pediatrics medicine
Other areas of specialty/work
Street address
Medical college, Ghotb Ravandi boulevard
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
dr.goudarzi1984@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)