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IRCT20240129060837N1 IRCT 2024-03-15 Ahvaz University of Medical Sciences The effect of L-carnitine in non-alcoholic fatty liver disease Efficacy of L-carnitine in decrease of liver enzymes and liver fat content in patients with non-alcoholic fatty liver disease 2024-03-24 anticipated 102 Complete https://irct.ir/trial/75222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process will be such that, based on a predetermined list including the patient's row number and the type of intervention (drug or placebo) randomly assigned (Excel's rand function was used for randomization), eligible individuals will be sequentially enrolled into either the drug or placebo group, Blinding description: In this study, after obtaining informed consent from the patient regarding participation, the type of intervention (drug or placebo) is not disclosed. The visiting physician, guided by a pre-randomized list, determines whether the patient should receive the drug or placebo. However, other colleagues receiving intervention results for evaluation and analysis will remain unaware of which group the patient belonged to. 3 Nonalcoholic fatty liver disease. Intervention 1: Intervention group: Taking L-carnitine supplement at a dose of one gram every 12 hours for 3 months. Intervention 2: Control group: Taking placebo at a dose of one gram every 12 hours for 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ahmad Nezhadisalami
Imam Khomeini educational and therapeutic center, Azadegan St
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3292 3985 nejadisalami_a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ahmad Nezhadisalami
Imam Khomeini educational and therapeutic center, Azadegan St
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3292 3985 nejadisalami_a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) AST, ALT levels above the normal range Sonographic findings consistent with fatty liver No history of viral hepatitis or conditions such as hemochromatosis, Wilson’s disease, autoimmune hepatitis, alpha-1 antitrypsin deficiency or chronic liver disease 15 years no limit Both Significant alcohol consumption (more than 10 grams per day for women and more than 20 grams per day for men) Pregnant or breastfeeding women K76 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Taking L-carnitine supplement at a dose of one gram every 12 hours for 3 months Control group: Taking placebo at a dose of one gram every 12 hours for 3 months Decreased level of liver enzymes. Timepoint: Measurement of liver enzymes at the beginning of the study (before the start of the intervention) and 3 months after L-carnitine supplementation. Method of measurement: Check the level of liver enzymes in the serum by the laboratory. Reducing the amount of liver fat. Timepoint: Measurement of liver enzymes at the beginning of the study (before the start of the intervention) and 3 months after L-carnitine supplementation. Method of measurement: Tansabdominal ultrasound. Ahvaz University of Medical Sciences Approved 2024-03-11 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Imam Khomeini educational and therapeutic center, Azadegan St, Ahvaz, Khuzestan province Ahvaz Khouzestan Iran (Islamic Republic of)