Comparison of the effect of venesection (Fasd) with phlebotomy on serum ferritin changes in patients with non-alcoholic fatty liver disease and hyperferritinemia: a randomized clinical trial
Comparison of the effect of venessection (Fasd) with phlebotomy on serum ferritin changes in patients with non-alcoholic fatty liver disease and hyperferritinemia
Design
This study is a randomized clinical trial with a control group that is blinded to the assessor.
Settings and conduct
1Clients with non-alcoholic fatty liver disease and hyperferritinemia were referred to the medical centers of Golestan University of Medical Sciences in 1403, referred from gastroenterology specialist.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Age 18 to 60 years - ferritin ≥ 150 ng/dl for women and ferritin ≥ 200 ng/dl for men - ALT > 41u/l - fatty liver grade 2 or higher in ultrasound or definitive diagnosis of NAFLD in fibroscan
Exit criteria:
Faint's history during blood sampling, diabetes, severe cardiovascular disease, anemia (hemoglobin number less than 13 in men and less than 12 in women), presence of pregnancy and breastfeeding, and participation in the clinical study of other liver diseases in the previous 2 months From entering the present study
Intervention groups
In the intervention groups, in addition to providing lifestyle modification measures (diet and regular exercise = attached program) for non-alcoholic fatty liver and increasing ferritin, the treatment program of blood removal by phlebotomy or Venesection (once per visit) will be carried out. .
Main outcome variables
The main outcome is the reduction of ferritin during the 4 weeks of the study.
The secondary outcome is a decrease in blood pressure and a decrease in the amount of ALT enzyme during the 4 weeks of the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231025059862N2
Registration date:2024-07-10, 1403/04/20
Registration timing:registered_while_recruiting
Last update:2024-07-10, 1403/04/20
Update count:0
Registration date
2024-07-10, 1403/04/20
Registrant information
Name
Mehdi Zarvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3325 1653
Email address
dr.zarvandi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-29, 1403/04/09
Expected recruitment end date
2024-10-01, 1403/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of venesection (Fasd) with phlebotomy on serum ferritin changes in patients with non-alcoholic fatty liver disease and hyperferritinemia: a randomized clinical trial
Public title
Comparison of the effect of venesection (Fasd)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years - ferritin ≥ 150 ng/dl for women and ferritin ≥ 200 ng/dl for men - ALT > 41u/l - fatty liver grade 2 or higher in ultrasound or definitive diagnosis of NAFLD in fibroscan
Exclusion criteria:
Faint's history during blood sampling, diabetes, severe cardiovascular disease, anemia (hemoglobin number less than 13 in men and less than 12 in women), presence of pregnancy and breastfeeding, and participation in the clinical study of other liver diseases in the previous 2 months From entering the present study
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In the study, patients will be divided into two groups A (intervention group with bag phlebotomy) and B (intervention group with scalpel blade) by block randomization method. In this way, the size of the blocks is considered to be four. Therefore, according to the treatment groups, 6 different combinations are created. Therefore, in the form of random sampling, 22 blocks were randomly selected based on the table of random numbers obtained by the computer program, and based on that, the samples included in the study will be divided into different groups. This will continue until we reach a sufficient number of samples in each group. For example, if block number 1 is selected in the first selection, it means that the first and second samples enter group A, and the third and fourth samples enter group B, and another block will be selected for the next sample.
Blinding (investigator's opinion)
Single blinded
Blinding description
According to the type of intervention in the present study, none of the studied patients will be blind to the intervention. However, in the process of data collection and evaluation of the fatty liver condition of the studied patients, the evaluators will be blinded to the type of intervention of the patients, and information about the type of intervention will not be given to avoid the possibility of information errors.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Floor 7, Phoenix building, At the end of Azar Alley 9.
Intervention group: In the phlebotomy group, venous blood was injected from the median cubital vein of the right upper limb by a syringe head with a Pharmed company bag in the amount of 500 cc.
Category
Treatment - Other
2
Description
Intervention group: in the Venesection group, with a scalpel number 11 by making a 2 mm long incision in the wall of the said vein. The amount of 500 cc will be collected outside and in graduated containers or plastic receivers.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers of Golestan University of Medical Sciences
Full name of responsible person
Mehdi Zarvandi
Street address
At the end of Azar Alley 9- Phoenix building, 7th floor
City
Gorgan
Province
Golestan
Postal code
4917613787
Phone
+98 915 551 2909
Email
leg_med_ny@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
7th floor, Phoenix building, at the end of Azar 9 alley
City
Gorgan
Province
Golestan
Postal code
4917613787
Phone
+98 915 551 2909
Email
leg_med_ny@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mehdi Zarvandi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
7th floor, Phoenix building, at the end of Azar 9 alley
City
Gorgan
Province
Golestan
Postal code
4917613787
Phone
+98 915 551 2909
Email
leg_med_ny@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mehdi Zarvandi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
7th floor, Phoenix building, at the end of Azar 9 alley
City
Gorgan
Province
Golestan
Postal code
4917613787
Phone
+98 915 551 2909
Email
leg_med_ny@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mehdi Zarvandi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
7th floor, Phoenix building, at the end of Azar 9 alley
City
Gorgan
Province
Golestan
Postal code
4917613787
Phone
+98 915 551 2909
Email
leg_med_ny@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information".
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available