| Trial ID: | L0405 |
| Source ID: | IRCT20200531047614N2
|
| Associated Drug: |
Melatonin
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| Title: |
The effects of melatonin supplementation compared with placebo on ultrasound findings and metabolic profiles in obese children and adolescents with nonalcoholic fatty liver disease
|
| Acronym: |
--
|
| Status: |
Recruiting
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| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non alcoholic fatty liver disease (NAFLD). <br>Nonalcoholic steatohepatitis (NASH);K75.81
|
| 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: two Placebo tablets (Simorgh Darou Attar Co., Iran),
|
| Outcome Measures: |
Hs-CRP. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Elisa kit.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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| Sponsor/Collaborators: |
Kashan University of Medical Sciences
|
| Gender: |
All
|
| Age: |
10 years18 years
|
| Phases: |
Phase 3
|
| Enrollment: |
66
|
| Study Type: |
interventional
|
| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 66 by a random nu
|
| Start Date: |
13/11/2020
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| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
30 November 2020
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/51620
|
