Effects of Melatonin on Non-alcoholic fatty liver disease

Evaluation of the effects of Melatonin Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid profile, blood glucose, Insulin Sensitivity, and Hepatic Steatosis grade in patients with Non-alcoholic fatty liver disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016061516123N8

Enrollment

Registered

2016-08-28

Start date

2016-09-22

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

Nonalcoholic fatty liver disease (NAFLD). nonalcoholic steatohepatitis

Interventions

Intervention 1: Melatonin, Tab 5 mg, once a dayT 3 months. Intervention 2: Placebo, 5 mg, 3 months.

Treatment - Other

Placebo

Melatonin, Tab 5 mg, once a dayT 3 months

Placebo, 5 mg, 3 months

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: A - Inclusion criteria: Age 18 years and older; with evidence of nonalcoholic fatty liver in ultrasonography with a higher degrees and equal 2 of steatosis; the liver enzyme concentration (alanine aminotransferase or ALT) greater than 1.5 times the highest normal. b -exclusion criteria: history of alcohol consumption; chronic and acute liver disorders (hepatitis B, C, ...); biliary diseases; autoimmune diseases; cancer; hereditary disorders affecting on liver condition (storage disease of iron, copper, ...); cardiovascular; pulmonary diseases; kidney diseases; pregnancy; breast-feeding; use of contraceptives; hepatotoxic drugs consumption; use of Mineral- multivitamin supplements; weight loss surgery in the past year; weight loss program in 3 month ago; history of hypothyroidism; Cushing's syndrome.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Alanine transaminase. Timepoint: before intervention and after 3 months. Method of measurement: seum level.;Aspartate transaminase. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Tumor necrosis factor alpha. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;High sensitive C reactive protein. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Triglyceride. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Total cholesterol. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Low density lipoprotein (LDL). Timepoint: before intervention and after 3 months. Method of measurement: serum level.;High density lipoprotein (HDL). Timepoint: before intervention and after 3 months. Method of measurement: serum level.	—

Measure

Time frame

Alanine transaminase. Timepoint: before intervention and after 3 months. Method of measurement: seum level.;Aspartate transaminase. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Tumor necrosis factor alpha. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;High sensitive C reactive protein. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Triglyceride. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Total cholesterol. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Low density lipoprotein (LDL). Timepoint: before intervention and after 3 months. Method of measurement: serum level.;High density lipoprotein (HDL). Timepoint: before intervention and after 3 months. Method of measurement: serum level.

—

Secondary

Measure	Time frame
Sleep quality. Timepoint: before and 3 months after intervention. Method of measurement: Pittsburgh sleep quality index questionnaire.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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