Melatonin supplementation in treatment of obese children and adolescents with nonalcoholic fatty liver disease

The effects of melatonin supplementation compared with placebo on ultrasound findings and metabolic profiles in obese children and adolescents with nonalcoholic fatty liver disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200531047614N2

Enrollment

Registered

2020-11-13

Start date

2020-11-05

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Non alcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH)

Interventions

Intervention 1: Intervention group: two melatonin tablets (Simorgh Darou Attar Co., Iran) 6 mg, 3 mg each tablet, once a day, one hour before bedtime for 16 weeks orally. Intervention 2: Control group

Eligibility

Sex/Gender

All

Age

10 Years to 18 Years

Inclusion criteria

Inclusion criteria: Obese children and adolescents diagnosed with nonalcoholic fatty liver. Patients aged 10-18 years old.

Exclusion criteria

Exclusion criteria: Taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment. Patients with infectious and autoimmune diseases Hypersensitivity to the study medication.

Design outcomes

Primary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Elisa kit.	—

Secondary

Measure	Time frame
Severity of liver steatosis. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Sonography.;Serum liver enzymes. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Severity of liver steatosis. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Sonography.;Serum liver enzymes. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Sharif

Kashan University of Medical Sciences

mrsharifmd@yahoo.com+98 31 5554 0026

Outcome results

None listed

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