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The effect of folate supplementation on Non Alcoholic Fatty Liver Disease treatment

Phase 2
Conditions
on alcoholic fatty liver.
Fatty (change of) liver
Registration Number
IRCT2015051710333N2
Lead Sponsor
Ilam University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Male
Target Recruitment
40
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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