The effect of coenzyme Q10 supplement on Prevention of hepatotoxicity Caused by iron-overload in patients with major β-thalassemia referred to Hajar Hospital
Determining the effect of co-enzyme Q10 supplementation on reducing liver damage caused by increased iron in patients with thalassemia major referred to Hajar Hospital.
Design
The present semi-experimental study will be conducted on 50 thalassemia major patients. This study is a phase 3 clinical trial. This study is before and after and does not have a control group. In addition to the standard treatment (iron chelators such as deferoxamine, deferasirox, etc), the patients also receive a 100 mg co-enzyme Q10 tablet daily for eight weeks.
Settings and conduct
Fifty patients are chosen among the thalassemia patients referred to Shahrekord Hajar Hospital in 2023. These participants are chosen based on similarities (individuals with similar blood collection intervals). A before-and-after investigation will be carried out. There is no control group. Before intervention the following parameters ALT, AST, HB, Ferritin, ESR, CRP, TIBC, LDH will be checked, and then, along with the standard treatment, they will be given a 100 mg co-enzyme Q10 tablet daily for eight weeks and the mentioned parameters are checked again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with thalassemia major
Exclusion criteria: viral hepatitis, use of hepatotoxic drugs
Intervention groups
The study will be a single group comparison before and after. The intervention group receives standard treatment + 100 mg Q10 tablets
Main outcome variables
Level of blood AST
Level of blood ALT
Level of blood LDH
Level of blood HB
Level of blood ferritin
Level of blood CRP
Measuring ESR
Measuring TIBC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221211056777N2
Registration date:2023-08-06, 1402/05/15
Registration timing:registered_while_recruiting
Last update:2023-08-06, 1402/05/15
Update count:0
Registration date
2023-08-06, 1402/05/15
Registrant information
Name
Shima Rahmati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 5131
Email address
rahmati.sh@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-02, 1401/12/11
Expected recruitment end date
2023-08-27, 1402/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coenzyme Q10 supplement on Prevention of hepatotoxicity Caused by iron-overload in patients with major β-thalassemia referred to Hajar Hospital
Public title
The effect of coenzyme Q10 supplement on Prevention of hepatotoxicity in patients with major β-thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with thalassemia major
Patients with thalassemia major with elevated liver enzymes
Patients with thalassemia major with elevated inflammation markers
Exclusion criteria:
Patients with active viral hepatitis
Hepatotoxic drugs consumption
Hypersplenism
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 of Shahrekord University of Medical Sciences
Street address
Kashani street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.SKUMS.REC.1401.061
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Level of aspartate aminotransferase (AST) in blood
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Biochemical laboratory kit
2
Description
Level of alanine transaminase (ALT) in blood
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Biochemical laboratory kit
3
Description
Level of hemoglobin (Hb) in blood
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Biochemical laboratory kit
4
Description
Level of ferritin in blood
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Biochemical laboratory kit
5
Description
Measuring erythrocyte sedimentation rate (ESR)
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Biochemical laboratory kit
6
Description
Level of C-reactive protein (Crp) in blood
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Biochemical laboratory kit
7
Description
Measuring Total iron binding capacity (TIBC)
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Biochemical laboratory kit
8
Description
Level of lactate dehydrogenase (LDH) in blood
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Biochemical laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
50 individuals with major thalassemia will be selected. Laboratory parameters (ALT, AST, HB, Ferritin, ESR, CRP, TIBC, LDH) will be examined initially and recorded along with demographic information in a checklist made by the researcher. Along with standard treatment (iron chelators such as deferoxamine, deferasirox, etc) they will also receive a daily dose of 100mg of Co-enzyme Q10 tablets (Golden Life) for eight weeks. After the eight weeks of medication, the parameters will be examined again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Hajar hospital
Full name of responsible person
Milad Nami
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 913 985 4865
Email
miladnami75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Reisi
Street address
Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 9507
Email
shimarahmati1987@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Milad Nami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
miladnami75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kiavash Fekri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
0098383222116
Email
k.fekri@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Milad Nami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 1166
Email
miladnami75@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.
From where data/document is obtainable
In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address miladnami75@gmail.com or the contact number 00989117640474
What processes are involved for a request to access data/document
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.