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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190901044662N1

Enrollment

Registered

2019-11-07

Start date

2019-12-21

Completion date

Unknown

Last updated

2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified

Interventions

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

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
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShadi Zarringol

Kashan University of Medical Sciences

zarringol-sh@kaums.ac.ir+98 31 5554 0026

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026