The aim of this study will be to determine the effect of vitamin E and metformin on improvement children with nonalcoholic fatty liver disease. Inclusion criteria will be included: body mass index above 95 percent and the risk of non-alcoholic fatty liver. Exclusion criteria will be included diabetes or pre-diabetes patients, obesity-related hereditary diseases and chronic kidney or liver disease. Statistical population of this study will be all children from 10 to 14-year-old non-diabetic obese patients with non-alcoholic fatty liver (biopsy-proven or ultrasound). Sample size will be 200 patients (in four groups). Intervention and its time will be included: the first group of patients treated with metformin at a dose of 500 mg twice a day; the second group of patients treated with vitamin E 800 IU capsule once a day; the third group of patients treated with metformin 500 mg twice daily and vitamin E 800 IU capsule once a day; the fourth group of patients treated with placebo once a day. The initial consequences of the intervention are unclear. The Primary outcome variables will be fasting blood glucose, lipid profile, body mass index, levels of fasting insulin, insulin sensitivity, alanine aminotransferase and aspartate aminotransferase.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061334514N1
Registration date:2017-08-03, 1396/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-03, 1396/05/12
Registrant information
Name
Moaz Alhaddad
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8709
Email address
m.alhaddad@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the role of vitamin E and metformin in improving children with fatty liver
Public title
Investigating the role of vitamin E and metformin in improving fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
The aim of this study will be to determine the effect of vitamin E and metformin on improvement children with nonalcoholic fatty liver disease.
Inclusion criteria include:
1-Age 8 to 14 years
2-Body mass index above 95 percent,
3-The risk of non-alcoholic fatty liver.
Exclusion criteria include:
1-Patients suffering from diabetes or pre-diabetes patient
2-BMI below 95 percent
3-History of alcohol use
4-The risk of obesity-related diseases such as hereditary syndrome, Prader Willi;
5-Pathological obesity cushingoid such as syndrome, hypothyroidism, Hypo Pseudo hyperparathyroidism
6-The risk of chronic diseases such as kidney or liver cirrhosis, viral hepatitis;
7-Lack of parental consent to participate in the study.
Age
From 8 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Shahid Bahonar St.
City
Qazvin
Postal code
Approval date
2017-05-17, 1396/02/27
Ethics committee reference number
13935/20/28 ir.qums.rec.1396.88
Health conditions studied
1
Description of health condition studied
Fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
fasting blood glucose
Timepoint
Before treatment and at the second and fourth month of treatment
Method of measurement
Standard protocol
2
Description
lipid profile
Timepoint
Before treatment and at the second and fourth month of treatment
Method of measurement
Standard protocol
3
Description
Body mass index
Timepoint
Before treatment and at the second and fourth month of treatment
Method of measurement
Standard protocol
4
Description
levels of fasting insulin
Timepoint
Before treatment and at the second and fourth month of treatment
Method of measurement
Standard protocol
5
Description
insulin sensitivity
Timepoint
Before treatment and at the second and fourth month of treatment
Method of measurement
Standard protocol
6
Description
alanine aminotransferase
Timepoint
Before treatment and at the second and fourth month of treatment
Method of measurement
Standard protocol
7
Description
Aspartate aminotransferase
Timepoint
Before treatment and at the second and fourth month of treatment
Method of measurement
Standard protocol
Secondary outcomes
1
Description
BMI
Timepoint
11 month
Method of measurement
BMI Formula
Intervention groups
1
Description
treated with metformin
Category
Treatment - Drugs
2
Description
treated with Vit. E
Category
Treatment - Drugs
3
Description
treated with metformin + Vit. E
Category
Treatment - Drugs
4
Description
placebo-treated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Center
Full name of responsible person
Maaz Alhaddad
Street address
Quds Hospital, Quds Square, Shahid Beheshti St. Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Qazvin university of medical sciences, Shahid Bahonar St. Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Saffari
Position
associated prof.
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Qods Center