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IRCT20170628034786N3 IRCT 2021-04-26 Esfahan University of Medical Sciences The effect of astaxanthin supplementation on cytokeratin 18 levels The effect of astaxanthin supplementation on cytokeratin 18 levels in children and adolescents with non-alcoholic fatty liver 2021-07-21 anticipated 58 Complete https://irct.ir/trial/55079 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: During random allocation, patients will be divided into two groups of interventional and placebo by permutation block method with blocks of volume 4. (Possible permutations are: AABB, ABAB, ABBA, BBAA, BABA, BAAB). Using the random permutation block method, the samples will be assigned to two groups. Random sequences are generated using R software and a randomizeR software package, Blinding description: In this research, patient, researcher and data analyser not know which patient receives the drug and which one receives a placebo. 3 Non alcoholic fatty liver. Intervention 1: Control group: The placebo will be taken once a day with lunch, which is quite similar in color and size to the main medicine. Intervention 2: Intervention group: Patients in the astaxanthin group will receive one 8 mg tablet containing astaxanthin daily with lunch for 8 weeks. Astaxanthin supplement is provided by Nature Vision company in USA. This supplement was made from the alga Haematococcus pluvialis. Yes - There is a plan to make this available What will be shared: After the implementation of the research, the results will be available to the scientific community. When: One Year after publication To whom: Professional Researchers in this field Conditions: After communication with the corresponding author of the project, the researchers in this field can access some statistical analysis file information Where to obtain: Principal Investigator Dr. Majid Khademian Isfahan University of Medical Sciences, Faculty of Medicine, Pediatric Department of Gastroenterology, khademian51@yahoo.com How to obtain: After E-Mail to the corresponding author of the project, they will be able to provide the documentation to them. khademian51@yahoo.com Comments:
public Majid Khademian
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3386 8247 khademian51@yahoo.com Esfahan University of Medical Sciences scientific Majid Khademian
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3386 8247 khademian51@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children with non- alcoholic fatty liver disease Age between 8-18 years old Elevation of liver enzyme more than 40 Unit/Litre Evidence of fatty liver in sonography 8 years 18 years Both Diagnosis of liver disease other than NAFLD such as : Viral hepatitis,Autoimmune hepatitis, Diabetes, Hemochromatosis, Cirrhosis, Infectious disease, Hypothyroidism Consumption of drugs that effect on liver enzyme during last two months Alcohol consumption Discontinuing the study by the patient or his/her family K76.0 Fatty (change of) liver, not elsewhere classified Placebo Treatment - Drugs Control group: The placebo will be taken once a day with lunch, which is quite similar in color and size to the main medicine Intervention group: Patients in the astaxanthin group will receive one 8 mg tablet containing astaxanthin daily with lunch for 8 weeks. Astaxanthin supplement is provided by Nature Vision company in USA. This supplement was made from the alga Haematococcus pluvialis. Serum level of Alanine aminotransferase. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Quantitative measurement of liver transaminase. Serum level of Aspartate aminotransferase. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Quantitative measurement of liver transaminase. Serum levels of cytokeratin 18. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Eliza method. Body fat mass. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Inbody 270 body composition measuring device. Lean body mass. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Inbody 270 body composition measuring device. Body mass index. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Measurement of height and weight and ratio of weight to square of height. Waist circumference. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Measurement with meters. Hip circumference. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Measurement with meters. Weight. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Measurement with scales. Height. Timepoint: Eight weeks after treatment initiation with placebo and astaxanthin. Method of measurement: Measurement with meters. Esfahan University of Medical science Approved 2021-04-06 Ethics committee ofIsfahan medical university Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)