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IRCT201503163320N10 IRCT 2015-07-02 Vice Chancellor for research of Tabriz University of Medical Sciences vitamin D and non-alcoholic fatty liver disease The effect of a single dose of vitamin D3 injection on serum 25 hydroxy vitamin D and adiponectin and liver function in women with non-alcoholic fatty liver disease 2015-04-05 anticipated 72 Complete https://irct.ir/trial/3406 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Non-alcoholic fatty liver disease. Intervention 1: control group: Vitamin E400, 1 capsule/day for one month. Intervention 2: Intervention Group: injection of vitamin D at the dose of 600000 IU at the beginning of study and Vitamin E400, 1 capsule/day for one month.
public Dr. Mehrangiz Ebrahimimamagani
Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
tabriz Iran (Islamic Republic of) +98 41 3334 1113 ebrahimimamagani@tbzmed.ac.ir Nutrition Faculty, Tabriz University of Medical Sciences scientific Dr. Mehrangiz Ebrahimimamagani
Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
Tabriz Iran (Islamic Republic of) +98 41 3334 1113 ebrahimimamagani@tbzmed.ac.ir Nutrition faculty, Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: willingness to participate in the study, 18-50 years old, liver steatosis on sonographic image, vitamin D deficiency(25(OH)D levels less than 30ng/ml), BMI≥25 Exclusion criteria: Alcohol consumption(more than 20g/day), menopause, gestation or lactation, BMI>40, diabetes and insulin resistance, any other liver disease(viral disease, Wilson, Hemochromatosis, glycogen storage disorders and etc) or using drugs for the treatment of fatty liver(such as omega-3 and herbal supplements), Thyroid and parathyroid disorders, bone problems, Cushing's syndrome, fat malabsorption, cholecystectomy and any other disease that affect the liver, renal disease(renal failure and nephrolithiasis), using vitamin D, calcium and vitamin E supplements in the past 6 months, taking any drugs causing fatty liver or hepatotoxic drugs(calcium channel blocker,methotrexate,tamoxifen, valproate, diltiazem, amiodarone, isoniazid, corticosteroids and high-dose of estrogen and progestin, and the use of contraceptives), taking drugs affecting insulin resistance and liver function(Such as metformin, pioglitazone, lovastatin and etc.), get weight loss diet in the past 6 months, using total parenteral nutrition in the past 6 months. 18 years 50 years Female K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs control group: Vitamin E400, 1 capsule/day for one month Intervention Group: injection of vitamin D at the dose of 600000 IU at the beginning of study and Vitamin E400, 1 capsule/day for one month Serum 25(OH)D. Timepoint: Beginning and end of the intervention. Method of measurement: ELIZA. Serum Adiponectin. Timepoint: Beginning and end of the intervention. Method of measurement: ELIZA. Liver Enzyme (ALT,AST,ALP). Timepoint: Beginning and end of the intervention. Method of measurement: IFCC. Liver steatosis. Timepoint: Beginning and end of the intervention. Method of measurement: Liver Sonography. Anthropometry. Timepoint: Begining and end of intervention. Method of measurement: Scale and meter and bioelectrical impedance analyzer. Energy and nutrient intake. Timepoint: Beginning and end of the intervention. Method of measurement: 24- hour dietary recall. Physical activity. Timepoint: Begining and end of intervention. Method of measurement: Physical activity Questionnaire. Sun exposure. Timepoint: Begining and end of intervention. Method of measurement: Questionnaire. Vice Chancellor for research of Tabriz University of Medical Sciences Approved 2015-05-04 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht Street,Tabriz Tabriz Iran (Islamic Republic of)