Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: The intervention group will receive one tablet contains 1000 microgram vitamin B12 daily for 12 weeks. Intervention 2: Control group: The control group will receive
Sponsors
Kashan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Pregnancy Lactation Alcohol consumption greater than 20 g per day Having diseases such as hereditary hemochromatosis, Wilson's disease and a1 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of liver steatosis. Timepoint: At baseline and 12 weeks after the start of the intervention. Method of measurement: The real-time 2-dimensional shear wave elastography device.;Grade of liver fibrosis. Timepoint: At baseline and 12 weeks after the start of the intervention. Method of measurement: The real-time 2-dimensional shear wave elastography device.;Serum level of alanine transaminase. Timepoint: At baseline and 12 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 12 weeks after the start of the intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of homocystein. Timepoint: At baseline and 12 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Insulin resistance. Timepoint: At baseline and 12 weeks after the start of the intervention. Method of measurement: By the formula of homeostatic model assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum level of triglyceride. Timepoint: At baseline and 12 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 12 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 12 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 12 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamidreza Talari
Kashan University of Medical Sciences
Outcome results
None listed