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Recruitment centers
#1
Name of recruitment center - English: Baghaei 2 Hospital
Name of recruitment center - Persian: بیمارستان بقایی 2
Full name of responsible person - English: Kambiz Davari
Full name of responsible person - Persian: کامبیز داوری
Street address - English: Golestan Blvd-Baghaei 2 hospital
Street address - Persian: بلوار گلستان-بیمارستان بقایی 2
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 912 349 6607
Fax:
Email: Kdatzums@yahoo.com
Web page address:
Name of recruitment center - English: Zanjan city hospitals
Name of recruitment center - Persian: بیمارستان های شهر زنجان
Full name of responsible person - English: Kambiz Davari
Full name of responsible person - Persian: کامبیز داوری
Street address - English: Zanjan city hospitals
Street address - Persian: بیمارستان های شهر زنجان
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Country: Iran (Islamic Republic of)
Postal code: ۴۵۱۳۹۵۶۱۱۱
Phone: +98 912 349 6607
Fax:
Email: Kdatzums@yahoo.com
Web page address:
Name of recruitment center - English: Baghaei 2 HospitalZanjan city hospitals Name of recruitment center - Persian: بیمارستان بقایی 2های شهر زنجان Full name of responsible person - English: Kambiz Davari Full name of responsible person - Persian: کامبیز داوری Street address - English: Golestan Blvd-Baghaei 2 hospitalZanjan city hospitals Street address - Persian: بلوار گلستان-بیمارستان بقایی 2های شهر زنجان City - English: AhvazZanjan City - Persian: اهواززنجان Province: KhouzestanZanjan Country: Iran (Islamic Republic of) Postal code: 61357-15794۴۵۱۳۹۵۶۱۱۱ Phone: +98 912 349 6607 Fax: Email: Kdatzums@yahoo.com Web page address:
Protocol summary
Study aim
The purpose of this study is to investigate the effect of supplementation with selenium antioxidant on inflammatory markers and neutrophil to lymphocyte ratio as a measure of immune system function in patients with thalassemia.
Design
Randomized 42 patients were studied. The sampling method will be both before and after supplemental therapy and fasting.
Settings and conduct
In a randomized clinical trial, 42 patients with thalassemia major or intermedia in Khuzestan province are selected from among those who refer to Baghaei 2 hospital in Ahvaz city. Selenium tablets of 200 μg are given to the patients daily for one month after receiving the first dose. At the beginning of the treatment, and one month after the start of the treatment, peripheral blood samples are taken from the patients and the main outcome variables are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Having thalassemia major or intermedia
• Healthy liver and kidney function
Exit criteria:
• Severe heart, liver, or kidney failure
• History of chemotherapy
• Diabetes patients
• Patients with fever and acute and chronic inflammatory infections
• Taking any selenium supplement at least two months before the study
Intervention groups
42 patients with thalassemia major or intermedia are selected according to the study criteria. Selenium tablets of 200 μg are given to the patients daily for one month after receiving the first dose. Inflammatory factors are measured before and after supplementation with selenium.
Main outcome variables
Determination of levels of IL-6, IL-1b, IL-2, TNF-a, CRP, neutrophil to lymphocyte ratio (N/L Ratio)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180603039959N3
Registration date:2023-02-06, 1401/11/17
Registration timing:prospective
Last update:2023-07-24, 1402/05/02
Update count:2
Registration date
2023-02-06, 1401/11/17
Registrant information
Name
bijan keikhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 0410
Email address
keikhaeib@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-21, 1401/12/02
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation with Selenium on serum inflammatory factors of beta thalassemia major patients.
Public title
Investigation of the effect of Selenium in beta thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having thalassemia major or intermedia
Healthy liver and kidney function
Exclusion criteria:
Severe heart, liver or kidney failure
History of chemotherapy
Diabetic patients
Patients with fever and acute and chronic inflammatory infections
Taking any selenium supplement for at least two months before the study
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Research Ethics Committees of Golestan Hospital
Street address
Golestan hospital, Farvardin Blvd, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
6138933333
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.140
Health conditions studied
1
Description of health condition studied
thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
TNF-alpha (TNF-a)
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure TNF-a.
2
Description
IL-6
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure IL-6.
3
Description
IL-1b
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure IL-1b.
4
Description
IL-2
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure IL-2.
5
Description
C-reactive protein (CRP)
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure CRP.
6
Description
Neutrophil to lymphocyte ratio (N/L Ratio)
Timepoint
Start of treatment, one month after treatment
Method of measurement
The ratio of neutrophils to lymphocytes (N/L ratio) is obtained from the results of complete blood count (CBC).
7
Description
The antioxidant superoxide dismutase (SOD)
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure SOD
8
Description
Thyroid Stimulating Hormone (TSH)
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure TSH
9
Description
Triiodothyronine (T3)
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure T3
10
Description
Thyroxine (T4)
Timepoint
Start of treatment, one month after treatment
Method of measurement
ELISA method is used to measure T4
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 42 patients with thalassemia major or intermedia are selected according to the study criteria. Selenium tablets of 200 μg are given to the patients daily for one month after receiving the first dose. Inflammatory factors are measured before and after supplementation with selenium.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan city hospitals
Full name of responsible person
Kambiz Davari
Street address
Zanjan city hospitals
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۹۵۶۱۱۱
Phone
+98 912 349 6607
Email
Kdatzums@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Baghaei 2 hospital Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3375 0410
Email
Kdatzums@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Kambiz Davari
Position
assistant Hematology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Baghaei 2 Hospital Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 41 3336 1658
Email
Kdatzums@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kambiz Davari
Position
assistant
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Baghaei 2 Hospital , Ahvaz city
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 41 3336 1658
Fax
Email
Kdatzums@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kambiz Davari
Position
assistant
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Baghaei 2 Hospital , Ahvaz city
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 41 3336 1658
Email
Kdatzums@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available