The aim of this study is to determine effectiveness of vitamin E and Pioglitazone in improving some biochemical markers in NAFLD. The study will be designed as a randomized double-blinded, placebo-controlled trial. We will be recruited consecutively NAFLD patients aged between 18 to 60 years from outpatient clinic of Shahid Motahari hospital (Marvdasht, Iran) during 6 months’ period. Inclusion criteria included patients with NAFLD confirmed by performing liver sonography and increased levels of liver enzymes AST and ALT. Exclusion criteria included a history of alcohol consumption, diabetes, chronic liver disease, use of drugs such as statin, fibrate. The patients will be randomly allocated into three study groups; group A subjects will be treated with only lifestyle modification and placebo. Group B subjects will be administered with lifestyle modification and Vitamin E 400 IU/day. Group C subjects will be administered with lifestyle modification and pioglitazone 15 mg/day. Treatment courses will be considered for three months. The primary outcome is biomarker changes of liver function test at initial and 3 months after intervention. In addition, we will be considered BMI and waist circumference as secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705016312N4
Registration date:2017-05-20, 1396/02/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Amir Anushiravani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1634 4292
Email address
anushirvan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2017-10-30, 1396/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin E and Pioglitazone in patients with non-alcoholic fatty liver disease in Marvdasht Hospital
Public title
Effect of Vitamin E and Pioglitazone in patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with NAFLD confirmed by performing liver sonography and increased levels of liver enzymes AST and ALT. Exclusion Criteria: History of alcohol consumption; diabetes; chronic liver disease; use of drugs such as statin, fibrate.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.SUMS.MED.REC.1396.12
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K75.8
ICD-10 code description
Nonalcoholic steatohepatitis
Primary outcomes
1
Description
liver function test
Timepoint
Before intervention - 3 months after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before intervention - 3 months after intervention
Method of measurement
By BMI Formula
Intervention groups
1
Description
Intervention group: lifestyle modification and Vitamin E 400IU/day for 3 months
Category
Treatment - Drugs
2
Description
Intervention group: lifestyle modification and pioglitazone 15 mg/day for 3 months
Category
Treatment - Drugs
3
Description
Control group: lifestyle modification and placebo for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital and Clinic
Full name of responsible person
Amir Anushiravani
Street address
Motahari hospital and clinic, Moalem Square
City
Marvdasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University Of Medical Science
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
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, Shiraz University Of Medical Science
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
International branch_Shiraz University of Medical Sciences
Full name of responsible person
Niloofar Hadadi
Position
Medical Intern
Other areas of specialty/work
Street address
Medical School, International branch_Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 3623 4504
Fax
Email
hadadi.niloufar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Anushiravani
Position
Fellow in Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Department of Internal Medicine, Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 3634 4292
Fax
Email
anushirvan@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Anushiravani
Position
Fellow in gastroenterology and hepatology
Other areas of specialty/work
Street address
Department of Internal Medicine, Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71136344292
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)