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

Phase 3

Recruiting

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

• Registration Number: IRCT20180908040972N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 January 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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