Protocol summary

Summary
Aim of this study is comparison of fatty liver disease before and after treatment of ‏‏hypothyroidism in patients referred for ultrasonography. this study is a ‎clinical trial , double-blinded study of 105 patients who ‎were candidates for ultrasound to detect fatty liver. Patients perform blood tests ‎to detect hypothyroidism. Patients get ultrasound before and after treatment ‎with levothyroxine for diagnoses fatty liver.patients will receive 1.7 mg per day ‎Levothyroxine tablets. We will check ALT and AST, and alkaline phosphatase and ‎TSH and T4 before and after treatment for fatty liver.a radiologist ‎performs ultrasound to diagnose the severity of fatty liver before and after ‎treatment.‎ Inclusion criteria: 30 to 60 years; both gender; patients with fatty liver and ‏hypothyroidism; Lack of chronic liver disease Exclusion criteria: alcohol consumption; cancer

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017091820258N59
Registration date: 2017-09-23, 1396/07/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-23, 1396/07/01
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison fatty liver before and after treatment of ‏hypothyroidism
Public title
Comparison fatty liver before and after treatment of ‏hypothyroidism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 30 to 60 years; both gender; patients with fatty liver and ‏hypothyroidism; Lack of chronic liver disease Exclusion criteria: alcohol consumption; cancer
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.ARAKMU.REC.1396.62

Health conditions studied

1

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

Primary outcomes

1

Description
fatty liver
Timepoint
before and after treatment
Method of measurement
ultrasonography‎

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: treatment with 1.7 milligram in day levothyroxine ‎for diagnoses fatty liver.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Radiology Clinic
Full name of responsible person
Dr Fazeli Mosleh abadi
Street address
Valiasr Hospital, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Anoshirvani
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Kamran Ahmadi
Position
Resident of Radiology
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
ahmadi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Fazeli Moslehabadi
Position
Faculty Member
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
fazel@arak.mu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Kamran Ahmadi
Position
Resident of Radiology
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
ahmadi@arakmu.ac.ir
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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