| Trial ID: | L0711 |
| Source ID: | IRCT20120718010333N5
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| Associated Drug: |
Vitamin B12
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| Title: |
Comparison of the effect of vitamin B12 supplement with placebo on grade of liver steatosis and fibrosis based on the results of elastography in patients with Non-Alcoholic Fatty Liver Disease
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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 disease. <br>Fatty (change of) liver, not elsewhere classified;K76.0
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| Interventions: |
Intervention 1: Intervention group: The intervention group will receive one tablet contains 1000 microgram vitamin B12 daily for 12 weeks. Intervention 2: Control group: The control group will receive one tablet of placebo contains 1 mg maltodexterin dail
|
| Outcome Measures: |
Grade of liver steatosis. Timepoint: At baseline and 12 weeks after the start of the intervention. Method of measurement: The real-time 2-dimensional shear wave elastography device.;Grade of liver fibrosis. Timepoint: At baseline and 12 weeks after the start of the intervention. Method of measurement: The real-time 2-dimensional shear wave elastography device.;Serum level of alanine transaminase. Timepoint: At baseline and 12 weeks after the start of the intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of aspartate transaminase. Timepoint: At baseline and 12 weeks after the start of the intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of homocystein. Timepoint: At baseline and 12 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Insulin resistance. Timepoint: At baseline and 12 weeks after the start of the intervention. Method of measurement: By the formula of homeostatic model assessment.Serum level of triglyceride. Timepoint: At baseline and 12 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of C-reactive protein. Timepoint: At baseline and 12 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of malondialdehyde. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of low density lipoprotein cholesterol. Timepoint: At baseline and 12 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of high density lipoprotein cholesterol. Timepoint: At baseline and 12 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.
|
| Sponsor/Collaborators: |
Kashan University of Medical Sciences
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| Gender: |
All
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| Age: |
18 years80 years
|
| Phases: |
Phase 3
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| Enrollment: |
40
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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: Participants will be randomly assigned to the intervention or control group in the random blocks based on the random n
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| Start Date: |
25/12/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
26 May 2021
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| Locations: |
Iran (Islamic Republic of);Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/43262
|
