Non alcoholic fatty liver. Fatty (change of) liver
Conditions
Interventions
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.
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.
Sponsors
Ilam University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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 a1 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSoheila Samieepour
Vice Chancellor for Food and Drug, Ilam University of Medical Sciences
Outcome results
None listed