In this research, 40 eligible patients with non-alcoholic fatty liver disease referring to Qom gastroenterology clinic were chosen purposefully. Then, patients by block randomization were randomly divided into two control and intervention groups.
Settings and conduct
The study was performed as a randomized clinical trial at Shahid Beheshti Hospital in Qom. The study is single-blinded, and intervention is conducted by someone other than the care provider, and care provider is unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
patient was included in this study that, aged 18 to 65 years old and they are not anemic and by laboratory tests and fibroscan, non-alcoholic fatty liver disease has been proven in them. Patients with underlying illness will also be excluded from the study.
Intervention groups
For the intervention group after fibroscan and diagnosis of the disease in the first and fifth months, phlebotomy (with a needle and a blood transfusion bag of 400 cc each time from the median cubital vein) and for the second group where the control group performed phlebotomy not to be. Both groups are advised to improve lifestyle (proper diet and exercise) and prescribe vitamin E
Main outcome variables
At the end of the sixth month, fibroscan and lab tests were performed for both groups for evaluation of fatty liver severity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161205031252N4
Registration date:2017-12-06, 1396/09/15
Registration timing:registered_while_recruiting
Last update:2017-12-06, 1396/09/15
Update count:0
Registration date
2017-12-06, 1396/09/15
Registrant information
Name
Ahmad Hormati
Name of organization / entity
Qom university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2053
Email address
hormatia@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
medical university of qom
Expected recruitment start date
2017-07-27, 1396/05/05
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of phlebotomy efficacy in improvement of liver fibrosis and its function among patients with non alcoholic steatohepatitis
Public title
Impact of phlebotomy on steatohepatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-65 years
proven steatohepatitis with sonography or fibro scan
Hb more than 13 in men and more than 12 in women
Informed consent
Exclusion criteria:
any other liver disease
history of alcohol use (more than 10gr daily for women and more than 20gr daily for men)
pregnant and lactating women
women in childbearing age with no reliable Contraception method
weight under 50kg
uncontrolled underlying disease
contraindication of vitamin E use
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization, Unit of randomization:individual
Blinding (investigator's opinion)
Single blinded
Blinding description
Care provider is blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
No. 83, 4th alley, 1.1 alley, Safashahr Blvd
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.MUQ.REC.1396.29
Health conditions studied
1
Description of health condition studied
Nonalcoholic steatohepatitis (NASH)
ICD-10 code
K75.8
ICD-10 code description
Other specified inflammatory liver diseases
Primary outcomes
1
Description
liver fibrosis
Timepoint
before intervention and after 6 month
Method of measurement
fibroscan
2
Description
liver function
Timepoint
before intervention and after 6 month
Method of measurement
Blood samples laboratory study
Secondary outcomes
1
Description
ferritin level
Timepoint
at the begining of study and 6 months later
Method of measurement
Laboratory blood level measurement
Intervention groups
1
Description
Intervention group: Phlebotomy at first and fifth months, (with a needle and a blood transfusion bag, 400 cc each time from the median cubital vein) with routine treatment