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IRCT201408312709N29 IRCT 2014-10-11 Vice chancellor for research, iran university of medical sciences Effect of vitamin D, vitamin D + calcium supplementation on nonalcoholic fatty liver disease The effect of vitamin D supplementation, vitamin D + calcium on fat storage in liver, serum lipoproteins and insulin sensitivity in patients with non-alcoholic fatty liver disease compared with controls. 2014-11-22 anticipated 80 Complete https://irct.ir/trial/2541 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Nonalcoholic fatty liver disease. Intervention 1: Placebo: two tablets contain lactose, produced in the company of jalinus, once daily, for 12 weeks. Intervention 2: Intervention: Vitamin D tablets. Contains 1000 international units of vitamin D, produced in the company of jalinus, once daily, for 12 weeks. Intervention 3: Intervention: One tablet contains 1000 international units of vitamin D + one tablet containing 500 mg of calcium, produced in the company of jalinus, once daily, for 12 weeks.
public Hamid Lorvand Amiri
Faculty of Health, Iran University of Medical Sciences, near milad Hospital, Shahid Hemmat Highway,Tehran, Iran.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2706 lorvandhamid@gmail.com Iran University of Medical Sciences scientific DR.farzad shidfar
Faculty of Health, Iran University of Medical Sciences, near milad Hospital, Shahid Hemmat Highway,Tehran, Iran.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2706 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Willingness to participate in this clinical trial, do not consume alcohol, not smoking, age 18 to 65 Years, BMI less than 35 (kilograms by the square of height), not taking certain medications (hepatotoxic drugs such as phenytoin, amiodarone, levothyroxine), not having these diseases (diabetes, heart, liver, kidney, lung), Not having inherited disorders affecting the liver (iron and copper storage disease, etc), not professional athlete, avoiding the use of nutritional supplements in the past 3 months. Exclusion criteria: Unwillingness to cooperate, taking nutritional supplements, pregnancy or lactation, smoking, alcohol consumption, intake of less than 70% of prescribed pills. 18 years 65 years Both K76.0 Fatty (change of) liver, not elsewhere classified Placebo Treatment - Drugs Treatment - Drugs Placebo: two tablets contain lactose, produced in the company of jalinus, once daily, for 12 weeks. Intervention: Vitamin D tablets. Contains 1000 international units of vitamin D, produced in the company of jalinus, once daily, for 12 weeks. Intervention: One tablet contains 1000 international units of vitamin D + one tablet containing 500 mg of calcium, produced in the company of jalinus, once daily, for 12 weeks CH. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: END POINT enzymatic method. Liver Fat. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Measured by ultrasound (normal - mild - moderate - severe). Hip circumference. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: By measuring tape. Percent body fat. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: BIA. HDL. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: DIRECT enzymatic method. LDL. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Using the Fried Wald Equation. TG. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: END POINT enzymatic method. FBS. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Glucose oxidase enzymatic colorimetric method. Fasting insulin. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: By ELISA (IRMA). Weight. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Scales. BMI. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Measured height and weight. Waist. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: tape. Vitamin D supplement. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Questionnaire. Placebo. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Questionnaire. Age. Timepoint: before the experiment. Method of measurement: Questionnaire. Height. Timepoint: before the experiment. Method of measurement: Tape. Energy intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Protein intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Carbohydrate intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Fat intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Cholesterol intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Vitamin E intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Vitamin C intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Vitamin A intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Omega3 intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Calcium intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Vitamin D intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire. Physical Activity. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: Questionnaire Physical Activity last 7 days. Vice chancellor for research, iran university of medical sciences Approved 2014-09-22 Ethics committee of Iran University of Medical Sciences Faculty of Health, Iran University of Medical Sciences, near milad Hospital, Shahid Hemmat Highway,Tehran, Iran Tehran Iran (Islamic Republic of)