The Effect of Vitamins B6, B9, B12 Supplementation in Treatment of Nonalcoholic Fatty Liver Disease

The Effect of Vitamins B6, B9, B12 Supplementation on Liver Enzymes, Inflammatory and Oxidative Stress Markers, Insulin Resistance, Lipid Profile and Serum Homocysteine in Overweight or Obese Patients with Nonalcoholic Fatty Liver Disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180908040972N1

Enrollment

Registered

2019-01-19

Start date

2018-10-01

Completion date

Unknown

Last updated

2019-01-29

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

Conditions

Condition 1: Nonalcoholic fatty liver disease. Condition 2: Overweight and obesity. Fatty (change of) liver, not elsewhere classified Obesity due to excess calories

Interventions

Intervention 1: Intervention group: Tablet containing vitamin B6 (20mg), vitamin B9 (1mg), vitamin B12 (50µg) once aday for 8 weeks. Intervention 2: Control group: Tablet containing maltodextrin once

Eligibility

Sex/Gender

All

Age

25 Years to 65 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in study Age range from 25 to 65 years Body mass index (BMI) from 25 to 40 kg /m2 Serum alanine aminotransferase (ALT) greater than the upper reference limit and steatosis grade > 1 on ultrasonography

Exclusion criteria

Exclusion criteria: Alcohol abuse (more than 20 grams per day in women and 30 grams per day in men) Acute and chronic liver diseases (all types of hepatitis? biliary disease? cirrhosis? inherited disorders affecting liver condition such as storage disease of iron, and copper? etc.) Gastrointestinal diseases (gastritis, celiac, steatorrhea, crohn, colitis, gastrointestinal bypass surgery, etc.) Hypertension and cardiovascular diseases Renal disease, lung disease, autoimmune diseases, rheumatoid arthritis, multiple sclerosis, cancer, thyroid disorders, epilepsy, diabetes All types of anemia, thalassaemia, A-beta-lipoproteinemia, hypoalbuminemia Hereditary disorders in homocysteine metabolizing enzymes Hepatotoxic drugs, gastric acid suppression drugs, antiepileptic drug and medications such as corticosteroids, contraceptive pills estrogen, progesterone, androgen, levodopa, cycloserine, phenelzine, isoniazid, penicillamine, sulfasalazine Weight loss during the last 6 months Follow special diet (weight loss diet, vegeterian diet, etc.) History of weight loss surgery in the last year Taking any dietary or herbal supplements during the last 6 months History of allergy or intolerance or unlikely side effects from taking vitamins B6? B9? B12 supplements Smoking Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Homocystein. Timepoint: At baseline and the end of week 8. Method of measurement: Colorimetric method.	—

Secondary

Measure	Time frame
Alanine transaminase (ALT). Timepoint: at baseline and the end of week 8. Method of measurement: Colorimetric method.;Aspartate transaminase (AST). Timepoint: at baseline and the end of week 8. Method of measurement: Colorimetric method.;High sensitivity C-reactive protein (hs-CRP). Timepoint: at baseline and the end of week 8. Method of measurement: ELISA.;Malondialdehyde (MDA). Timepoint: at baseline and the end of week 8. Method of measurement: Thiobarbituric acid method.;Fasting blood sugar (FBS). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;Insulin. Timepoint: at baseline and the end of week 8. Method of measurement: ELISA.;Triglyceride (TG). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;Total cholesterol (TC). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;High-density lipoprotein (HDL). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;Low-density lipoprotein (LDL). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;Serum vitamin B9. Timepoint: at baseline and the end of week 8. Method of measurement: ELISA.;Serum vitamin B12. Timepoint: at baseline and the end of week 8. Method of measurement: ELISA.;Anthropometric parameters. Timepoint: at baseline and the end of week 8. Method of measurement: Balance, meter.;Food intake. Timepoint: at baseline and the end of week 8. Method of measurement: 3-day food records.;Physical activity level. Timepoint: at baseline and the end of week 8. Method of measurement: International physical activity questionnaire short form (IPAQ-SF).	—

Measure

Time frame

Alanine transaminase (ALT). Timepoint: at baseline and the end of week 8. Method of measurement: Colorimetric method.;Aspartate transaminase (AST). Timepoint: at baseline and the end of week 8. Method of measurement: Colorimetric method.;High sensitivity C-reactive protein (hs-CRP). Timepoint: at baseline and the end of week 8. Method of measurement: ELISA.;Malondialdehyde (MDA). Timepoint: at baseline and the end of week 8. Method of measurement: Thiobarbituric acid method.;Fasting blood sugar (FBS). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;Insulin. Timepoint: at baseline and the end of week 8. Method of measurement: ELISA.;Triglyceride (TG). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;Total cholesterol (TC). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;High-density lipoprotein (HDL). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;Low-density lipoprotein (LDL). Timepoint: at baseline and the end of week 8. Method of measurement: Enzymatic method.;Serum vitamin B9. Timepoint: at baseline and the end of week 8. Method of measurement: ELISA.;Serum vitamin B12. Timepoint: at baseline and the end of week 8. Method of measurement: ELISA.;Anthropometric parameters. Timepoint: at baseline and the end of week 8. Method of measurement: Balance, meter.;Food intake. Timepoint: at baseline and the end of week 8. Method of measurement: 3-day food records.;Physical activity level. Timepoint: at baseline and the end of week 8. Method of measurement: International physical activity questionnaire short form (IPAQ-SF).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Hassan Eftekhari

Shiraz University of Medical Sciences

h_eftekhari@yahoo.com+98 71372510015

Outcome results

None listed

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