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The effect of Rosvastatin on steatosis and fibrosis in patients with non-alcoholic fatty liver disease: a randomized controlled clinical trial study

Protocol summary

Summary
The aim of this randomized controlled clinical trial study was to evaluate the effect of Rosvastatin on steatosis and fibrosis in patients with non-alcoholic fatty liver disease. From patients who were referred to gastrointestinal clinic of Tohid hospital, Sanandaj, Iran total of 40 patients with non-alcoholic fatty liver disease were selected. Main inclusion criteria included: Non diabetic patients, normal FBS, BS2hpp, Hb1AC, age 20 years and older, approved non fatty liver diagnosed by fibroscan, LFT (AST and ALT), rejection of other causes of fatty liver disease such as hepatitis B and C. Main exclusion criteria included: patients who have other liver diseases, contraindication for Rosvastatin, not taking hypoglycemic drugs such as metformin. Patients randomly divided into intervention and control groups. Patients and researchers were blinded and were not aware of grouping. In intervention group patients received 10 mg Rosvastatin daily plus standard treatment for fatty liver disease. In control group patients received placebo daily plus standard treatment for fatty liver disease. Before intervention and six months after the intervention AST and ALT were controlled and also, liver steatosis and liver fibrosis re-measured by fibroscan.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060212789N14
Registration date: 2017-06-12, 1396/03/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-12, 1396/03/22
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-20, 1396/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rosvastatin on steatosis and fibrosis in patients with non-alcoholic fatty liver disease: a randomized controlled clinical trial study
Public title
The effect of Rosvastatin on steatosis and fibrosis in patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Main Inclusion Criteria: Non diabetics patients; normal FBS; BS2hpp;Hb1AC; Age 20 years and older; approved non fatty liver diagnosed by fibroscan; LFT(AST and ALT); rejection of other causes of fatty liver disease such as hepatitis B and C . Main Exclusion Criteria: Patients who have other liver diseases; contraindication for Rosvastatin; not taking hypoglycemic drugs such as metformin.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Postal code
Approval date
2016-05-01, 1395/02/12
Ethics committee reference number
IR.MUK.REC.1395.284

Health conditions studied

1

Description of health condition studied
Nonalcoholic fatty liver disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
steatosis of liver
Timepoint
Before intervention, six month after intervention
Method of measurement
Fibroscan

2

Description
Fibrosis of liver
Timepoint
Before intervention, six month after intervention
Method of measurement
Fibroscan

Secondary outcomes

1

Description
ALT
Timepoint
Before intervention, six month after intervention
Method of measurement
Blood examination

2

Description
AST
Timepoint
Before intervention, six month after intervention
Method of measurement
Blood examination

3

Description
LDL
Timepoint
Before intervention, six month after intervention
Method of measurement
Blood examination

4

Description
HDL
Timepoint
Before intervention, six month after intervention
Method of measurement
Blood examination

5

Description
Triglyceride
Timepoint
Before intervention, six month after intervention
Method of measurement
Blood examination

6

Description
Bilirubin
Timepoint
Before intervention, six month after intervention
Method of measurement
Blood examination

7

Description
Blood urea
Timepoint
Before intervention, six month after intervention
Method of measurement
Blood examination

8

Description
Blood creatinine
Timepoint
Before intervention, six month after intervention
Method of measurement
Blood examination

Intervention groups

1

Description
Control Group: patients received placebo daily plus standard treatment for fatty liver disease.
Category
Treatment - Drugs

2

Description
Intervention Group: patients received 10 mg Rosvastatin daily plus standard treatment for fatty liver disease.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Dr. Nematillah Naghshbandi
Street address
Tohid Hospital, Geryashan St., Basij Sq., Sanandaj, Iran
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Ghaderi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Nematollah Naghshbandi
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Tohid Hospital, Geryashan St., Basij Sq., Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 6112
Fax
Email
dr.n.naghshbandi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Farshad Sheikhesmaili
Position
Associate Professor
Other areas of specialty/work
Street address
Tohid Hospital, Geryashan St., Basij Sq., Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 6112
Fax
Email
Dr_S_Smaili@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Nematollah Naghshbandi
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Tohid Hospital, Geryashan St., Basij Sq., Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 6112
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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