| Trial ID: | L0622 |
| Source ID: | IRCT201408312709N29
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| Associated Drug: |
Vitamin D
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| Title: |
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.
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Nonalcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
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| Interventions: |
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 d
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| Outcome Measures: |
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.
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| Sponsor/Collaborators: |
Vice chancellor for research, iran university of medical sciences
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| Gender: |
All
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| Age: |
18 years65 years
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| Phases: |
Phase 3
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| Enrollment: |
80
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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| Start Date: |
11/10/2014
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
22 February 2018
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/2541
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