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IRCT20150819023685N2 IRCT 2020-02-22 Ghoum University of Medical Sciences Efficacy of folic acid in the treatment of non-alcoholic fatty liver Efficacy of folic acid in the treatment of non-alcoholic fatty liver in patients with hepatic fibrosis 2020-04-20 anticipated 60 Complete https://irct.ir/trial/45681 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to the intervention or control group in the random blocks based on the random number table. The sequence of permuted blocks will be generated with a random number table. An individual with no clinical involvement in the trial, puts the lable of intervention or control group in an opaque and sealed envelope based on the random sequence. Then the other person, who is not aware of random sequences and the envelope content, will assign the patients to the intervention or control group, Blinding description: In the present study, participants, clinical caregiver, principal investigator, data analyzer and outcome evaluator will be blinded to the allocation to study groups. 3 Nonalcoholic steatohepatitis. Intervention 1: Intervention group: Folic acid tablet, 5 mg, oral, once a day, for 6 months. Intervention 2: Control group: placebo tablet, oral, once a day, for 6months. Yes - There is a plan to make this available What will be shared: A portion of the data regarding demographics variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared. When: The start of the data access period will be one year after the publication of the results. To whom: Researchers working in academic institutions Conditions: In order to conduct meta analysis studies Where to obtain: Samira Khani, Pharmacology Department, School of Medicine, Qom University of Medical Sciences, Ghadir Blvd., Qom, Iran Postal Code: 3736175513 E-mail: pharma_75@yahoo.com Tel: 00982533209071 How to obtain: An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request. Comments:
public Ahmad Hormati
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
Qom Iran (Islamic Republic of) 3719964797 0098 256122053 Hormatia@muq.ac.ir Ghoum University of Medical Sciences scientific Samira Khani
School of medicine,Pardis Campus, Ghadir Blvd
Qom Iran (Islamic Republic of) 3736175513 +98 25 3320 9071 pharma_75@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients who are diagnosed to have non alcoholic fatty liver disease (grade 2 and 3) confirmed with ultrasonography and fibroscan results. Ages between 18-65 years Serum alanine transaminase enzyme level higher than 30 U/L 18 years 65 years Both Having diseases such as liver disease and decompensated Cirrhosis Having diseases such as hereditary hemochromatosis and Wilson's disease Consumption of statins and hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone and chloroquine Intake of folate, B12, vitamin E and omega-3 supplements during the last 6 months History of receiving total parenteral nutrition during last 6 months Pregnancy Lactation K75.81 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Folic acid tablet, 5 mg, oral, once a day, for 6 months Control group: placebo tablet, oral, once a day, for 6months Liver stiffness. Timepoint: At baseline and 24 weeks after the start of the intervention. Method of measurement: Fibroscan. Blood levels of liver enzymes. Timepoint: At baseline and 24 weeks after the start of the intervention. Method of measurement: Blood test. Ghoum University of Medical Sciences Approved 2019-11-12 Ethics committee of Qom University of Medical Sciences No. 83, 4th alley, 1.1 alley, Safashahr Blvd Qom Ghoum Iran (Islamic Republic of)