| Trial ID: | L0480 |
| Source ID: | IRCT20180908040972N1
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| Associated Drug: |
Vitamin B
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| Title: |
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
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| Acronym: |
--
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| Status: |
Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Condition 1: Nonalcoholic fatty liver disease. Condition 2: Overweight and obesity. <br>Fatty (change of) liver, not elsewhere classified <br>Obesity due to excess calories
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| Interventions: |
Intervention 1: Intervention group: Tablet containing vitamin B6 (20mg), vitamin B9 (1mg), vitamin B12 (50??g) once aday for 8 weeks. Intervention 2: Control group: Tablet containing maltodextrin once aday for 8 weeks.
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| Outcome Measures: |
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).
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| Sponsor/Collaborators: |
Shiraz University of Medical Sciences
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| Gender: |
All
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| Age: |
25 years65 years
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| Phases: |
Phase 3
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| Enrollment: |
50
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| Study Type: |
interventional
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| Study Designs: |
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 pl
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| Start Date: |
19/01/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
29 January 2019
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/33813
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