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IRCT20180908040972N1 IRCT 2019-01-19 Shiraz University of Medical Sciences 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 2018-10-01 anticipated 50 Complete https://irct.ir/trial/33813 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients, after stratification based on age and sex, are randomly allocated to either a vitamins B6, B9, B12 or placebo group by block randomization, Blinding description: Supplement and placebo tablets are packaged by a person who hasn’t any involvement in the study. The packages are completely identical, each package is coded to A and B so the researchers, distributor, and participants are kept blinded to the allocation. 3 Condition 1: Nonalcoholic fatty liver disease. Condition 2: Overweight and obesity. 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 aday for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no information
public Dr. Mohammad Hassan Eftekhari
School of Nutrition and Food Sciences, Razi s.t, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) 7153675541 +98 71372510015 h_eftekhari@yahoo.com Shiraz University of Medical Sciences scientific Dr. Mohammad Hassan Eftekhari
School of Nutrition and Food Sciences, Razi s.t, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) 7153675541 +98 71372510015 h_eftekhari@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 25 years 65 years Both 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 K76.0 E66.0 Fatty (change of) liver, not elsewhere classified Obesity due to excess calories Treatment - Other Treatment - Other Intervention group: Tablet containing vitamin B6 (20mg), vitamin B9 (1mg), vitamin B12 (50µg) once aday for 8 weeks Control group: Tablet containing maltodextrin once aday for 8 weeks Homocystein. Timepoint: At baseline and the end of week 8. Method of measurement: Colorimetric method. 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). Shiraz University of Medical Sciences Approved 2018-07-03 Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences, Infront of Felestin St., Zand St. Shiraz Fars Iran (Islamic Republic of)