| Trial ID: | L0540 |
| Source ID: | IRCT2017053034222N1
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| Associated Drug: |
Calcitriol
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| Title: |
Effect of Calcitriol supplementation on the severity of fatty liver, inflammatory and metabolic biomarkers in patients with non-alcoholic fatty liver with different genotypes of vitamin D receptor
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver disease (NAFLD). <br>Fatty (change of) liver, not elsewhere classified
|
| Interventions: |
Intervention 1: 0.25 ??g/day calcitriol for 16 weeks. Intervention 2: Calcitriol placebo.
|
| Outcome Measures: |
Liver enzymes. Timepoint: Before and after 16 weeks calcitriol treatment. Method of measurement: Activity assay of enzymes in serum.Hepatic Steatosis. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: Fibroscan elastography and enzymatic assay of glyceamic and lipid parameters in serum.;High sensitive C-reactive protein (hs-CRP). Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: Enzyme-linked immunosorbent assay.;Total adiponectin. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: Enzyme-linked immunosorbent assay.;Serum leptin. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: Enzyme-linked immunosorbent assay.;Glycemic profile. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: By measuring fasting serum glucose and insulin.;Lipid profile. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: By enzymatic measurement of fasting serum triglyceride, cholesterol, HDL and LDL.
|
| Sponsor/Collaborators: |
Ahvaz Jundishapur University of Medical Sciences
|
| Gender: |
All
|
| Age: |
18 years60 years
|
| Phases: |
Phase 3
|
| Enrollment: |
160
|
| Study Type: |
interventional
|
| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with blocks of size 6 and random allocation to the blocks and allocation concealment was carried o
|
| Start Date: |
28/06/2017
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| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
26 March 2018
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/26203
|
