| Trial ID: | L0720 |
| Source ID: | IRCT20190901044662N1
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| Associated Drug: |
Folic acid
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| Title: |
Comparison of the effect of folic acid supplement with placebo on grade of liver steatosis, insulin resistance, inflammatory and oxidative stress biomarkers 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
|
| Results: |
--
|
| Conditions: |
Non-alcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;K76.0
|
| Interventions: |
Intervention 1: Intervention group: The intervention group will receive one tablet contains 1 mg folic acid daily for 8 weeks. Intervention 2: Control group: The control group will receive one tablet of placebo contains 1 mg maltodexterin daily for 8 week
|
| Outcome Measures: |
Serum level of alanine transaminase. Timepoint: At baseline and 8 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 8 weeks after the start of the intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Insulin resistance. Timepoint: At baseline and 8 weeks after the start of the intervention. Method of measurement: By the formula of homeostatic model assessment.;The grade of fatty liver. Timepoint: At baseline and 8 weeks after the start of the intervention. Method of measurement: By using ultrasonography.Serum level of folate. Timepoint: At baseline and 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of homocystein. Timepoint: At baseline and 8 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 8 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 8 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 8 weeks after the start of intervention. Method of measurement: Laboratory clinical kit and analyzer instrument.;Serum level of triglyceride. Timepoint: At baseline and 8 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
|
| Age: |
18 years80 years
|
| Phases: |
Not applicable
|
| Enrollment: |
66
|
| Study Type: |
interventional
|
| 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: |
07/11/2019
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| Completion Date: |
--
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| Results First Posted: |
--
|
| Last Update Posted: |
17 December 2019
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/41859
|
