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IRCT20190901044662N1 IRCT 2019-11-07 Kashan University of Medical Sciences Effect of folic acid in treatment of fatty liver disease Comparison of the effect of folic acid supplement with placebo on grade of liver steatosis, insulin resistance, inflammatory and oxidative stress biomarkers in patients with non-alcoholic fatty liver disease 2019-12-21 anticipated 66 Complete https://irct.ir/trial/41859 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. N/A Non-alcoholic fatty liver disease. Intervention 1: Intervention group: The intervention group will receive one tablet contains 1 mg folic acid daily for 8 weeks. Intervention 2: Control group: The control group will receive one tablet of placebo contains 1 mg maltodexterin daily for 8 weeks. Yes - There is a plan to make this available What will be shared: A portion of the data regarding demographics, anthropometric, and food 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: Nasrin Sharifi, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608 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 Shadi Zarringol
Pezeshk Ave., Qotb-e-Ravandi Blvd.
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0026 zarringol-sh@kaums.ac.ir Kashan University of Medical Sciences scientific Nasrin Sharifi
Pezeshk Ave., Qotb-e-Ravandi Blvd.
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5562 0608 sharifi-na@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients who are diagnosed to have non alcoholic fatty liver disease confirmed with ultrasonography result Ages between 18-80 years Serum alanine transaminase enzyme level higher than 30 U/L in men Serum alanine transaminase enzyme level higher than 19 U/L in women 18 years 80 years Both Pregnancy Lactation Alcohol consumption greater than 20 g per day Having diseases such as hereditary hemochromatosis, Wilson's disease and α1 antitripsin enzyme deficiency History of jejunoileal bypass surgery or gastroplasty History of receiving total parenteral nutrition during last 6 months Consumption of statins and hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine History of hypothyroidism and Cushing's syndrome Intake of folate, B12, vitamin E and omega-3 supplements during the last 3 months K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: The intervention group will receive one tablet contains 1 mg folic acid daily for 8 weeks. Control group: The control group will receive one tablet of placebo contains 1 mg maltodexterin daily for 8 weeks. Serum level of alanine transaminase. Timepoint: At baseline and 8 weeks after the start of the intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum level of aspartate transaminase. Timepoint: At baseline and 8 weeks after the start of the intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Insulin resistance. Timepoint: At baseline and 8 weeks after the start of the intervention. Method of measurement: By the formula of homeostatic model assessment. The grade of fatty liver. Timepoint: At baseline and 8 weeks after the start of the intervention. Method of measurement: By using ultrasonography. Serum level of folate. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum level of homocystein. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum level of C-reactive protein. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum level of malondialdehyde. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum level of low density lipoprotein cholesterol. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum level of high density lipoprotein cholesterol. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum level of triglyceride. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. Kashan University of Medical Sciences Approved 2019-10-21 Ethics committee of Kashan University of Medical Sciences Pezeshk Ave., Qotbe Ravandi Blvd. Kashan Isfehan Iran (Islamic Republic of)