]>
IRCT2015051710333N2 IRCT 2015-10-27 Ilam University of Medical Sciences The effect of folate supplementation on Non Alcoholic Fatty Liver Disease treatment The effect of folate supplementation on serum hepatic enzymes, lipid profile and homocystein levels in patients with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled trial 2015-10-17 anticipated 40 Complete https://irct.ir/trial/10845 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Non alcoholic fatty liver. Intervention 1: Intervention: Tablet contains 1 mg folate, once a day for 8 weeks. Intervention 2: Control: One placebo tablet contains edible starch, once a day for 8 weeks.
public Soheila Samieepour
Vice Chancellor for Food and Drug, IlamUniversity of Medical Sciences, Shahid Keshvari Sq.
Ilam Iran (Islamic Republic of) +98 84 3223 2523 sarma1364@gmail.com Vice Chancellor for Food and Drug, Ilam University of Medical Sciences scientific Nasrin Sharifi
Faculty of Medicine, Kashan University of Medical Sciences, Ghotb Ravandi Blvd
Kashan Iran (Islamic Republic of) +98 31 5554 0021 sharifi.nsr@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Diagnosis to have non alcoholic fatty liver disease confirmed with ultrasonography result; ages above 18 ; serum alanine transaminase enzyme level higher than 30 U/L ; Diabetic patients will include if they have been recently diagnosed with diabetes and not using blood glucose lowering drugs or if they consume insulin and metformin, it would pass at least 6 months from starting the treatment and during this period the dose of metformin and insulin are not changed. Exclusion criteria: Alcohol consumption greater than 20 g per day; diseases such as hereditary hemochromatosis; Wilson's disease; an enzyme deficiency α1 Antitripsin; history of jejunoileal bypass surgery or gastroplasty; experience to perform the total parenteral nutrition at 6 months before; consomption of statins and hepatotoxic drugs such as calcium channel blocker; methotrexate; amiodarone; chloroquine; a history of hypothyroidism and Cushing's syndrome; Intake of folate; B12; vitamin E; omega-3 supplements during last 6 months. 18 years 65 years Male K76.0 Fatty (change of) liver Treatment - Drugs Placebo Intervention: Tablet contains 1 mg folate, once a day for 8 weeks Control: One placebo tablet contains edible starch, once a day for 8 weeks. Serum Alanine Transaminase. Timepoint: Before and after intervention. Method of measurement: U/L - Laboratory kit. Grade of fatty liver based on ultrasonography results. Timepoint: Before and after intervention. Method of measurement: Ultrasonography scan. Serum Total cholestrol. Timepoint: Before and after intervention. Method of measurement: mg/dL - Laboratory kit. Serum LDL-C. Timepoint: Before and after intervention. Method of measurement: mg/dL- laboratory kit. Serum HDL-C. Timepoint: Before and after intervention. Method of measurement: mg/dL- laboratory kit. Serum Homocystein. Timepoint: Before and after intervention. Method of measurement: Laboratory kit-umol/Liter. Serum Triglyceride. Timepoint: Before and after intervention. Method of measurement: mg/dL- Laboratory kit. Serum Aspartate Transaminase (AST). Timepoint: Before and after intervention. Method of measurement: U/L- laboratory kit. Ilam University of Medical Sciences Approved 2015-09-29 Ethics Committee of Ilam University of Medical Sciences Ilam University of Medical Sciences, Pajoohesh Blvd. Ilam Iran (Islamic Republic of)