Investigating the role of vitamin E and metformin in improving fatty liver

Investigating the role of vitamin E and metformin in improving children with fatty liver

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017061334514N1

Enrollment

200

Registered

2017-08-03

Start date

2017-06-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: treated with metformin. Intervention 2: treated with Vit. E. Intervention 3: treated with metformin + Vit. E. Intervention 4: placebo-treated.

Treatment - Drugs

treated with metformin

treated with Vit. E

treated with metformin + Vit. E

placebo-treated

Eligibility

Sex/Gender

All

Age

8 Years to 14 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Fasting blood glucose. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Lipid profile. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Body mass index. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Levels of fasting insulin. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Insulin sensitivity. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Alanine aminotransferase. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Aspartate aminotransferase. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.	—

Measure

Time frame

Fasting blood glucose. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Lipid profile. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Body mass index. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Levels of fasting insulin. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Insulin sensitivity. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Alanine aminotransferase. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.;Aspartate aminotransferase. Timepoint: Before treatment and at the second and fourth month of treatment. Method of measurement: Standard protocol.

—

Secondary

Measure	Time frame
BMI. Timepoint: 11 month. Method of measurement: BMI Formula.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Saffari

Qazvin University of Medical Sciences

m.alhaddad@qums.ac.ir+98 283334807

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026