| Trial ID: | L0825 |
| Source ID: | IRCT201405251485N13
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| Associated Drug: |
Vitamin D
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| Title: |
The effect of vitamin D supplementation on serum concentrations of fibrogenic factors, vitamin D receptor and liver-related micro-RNAs in non-alcoholic fatty liver patients
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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: |
Non-alcoholic fatty liver. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
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| Interventions: |
Intervention 1: Intervention group will receive daily 1 tablets of vitamin D with meal for 12 weeks. Vitamin D tablets will be purchased from the Pars minoo Company. All the patients will be monitored for consumption of tablets by daily checklists and rec
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| Outcome Measures: |
Hyaluronic acid. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Laminin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Collagen type 4. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Vitamin D receptor. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;MiR-122. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Real-time PCR.;MiR-34a. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Real-time PCR.;MiR-21. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Real-time PCR.AST. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;PTH. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Nutritional status (calorie and nutrients intake). Timepoint: Every 2 weeks during the intervention. Method of measurement: Food record questionnaire.;Anthropometric index(weight, height,WHR and Body Mass Index). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Analogue scale for weight, height, WHR and weight(Kg)/Square Height for body mass index.;Physical activity. Timepoint: Every 2 weeks during the intervention. Method of measurement: International Physical Activity questionnaire.;Fasting blood glucose. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic colorimetric.;Fasting insulin serum. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: HOMA-IR calculation.;Insulin sensitivity. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: QUICKI calculation.;Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald?€?s formula: LDL-C = TC- HDL-C - (TG/5).;ALT. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.
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| Sponsor/Collaborators: |
Vice chancellor for Research, Tehran University of Medical Sciences
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| Gender: |
All
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| Age: |
20 years60 years
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| Phases: |
Phase 2/Phase 3
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| Enrollment: |
46
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -.
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| Start Date: |
14/03/2017
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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/772
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