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The effect of supplementation with Selenium on serum inflammatory factors of beta thalassemia major patients.

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History
# Registration date Revision Id
3 2023-07-23, 1402/05/01 272733
2 2023-03-17, 1401/12/26 259335
1 2023-02-06, 1401/11/17 255017
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  • Protocol summary

    یک کارآزمایی بالینی تصادفی، 42 بیمار تالاسمی ماژور یا اینترمدیا در استان خوزستان از بین مراجعه کنندگان به بیمارستان بقایی 2 شهر اهواز انتخاب می شوند. به بيماران قرص سلنیوم 200 میکروگرمی به صورت روزانه به مدت یک ماه پس از دریافت اولین دوز داده می شود. در شروع درمان ، و یک ماه بعد از شروع درمان نمونه خون محیطی از بیماران اخذ شده و متغیر های پیامد اصلی اندازه گیری می شوند.
    یک کارآزمایی بالینی تصادفی، 42 بیمار تالاسمی ماژور یا اینترمدیا در استان خوزستان از بین مراجعه کنندگان به بیمارستان بقایی 2 شهر اهواز انتخاب می شوند. به بيماران قرص سلنیوم 200 میکروگرمی به صورت روزانه به مدت یک ماه پس از دریافت اولین دوز داده می شود. در شروع درمان، و یک ماه بعد از شروع درمان نمونه خون محیطی از بیماران اخذ شده و متغیر های پیامد اصلی اندازه گیری می شوند.
    معیار های ورود: • ابتلا به تالاسمی ماژور یا اینترمدیا • عملکرد سالم کبد و کلیه معیار های خروج: • نارسایی قلبی، کبدی یا کلیوی شدید • سابقه ی شیمی درمانی • بیماران دیابت • بیماران دچار تب و عفونت های حاد و مزمن التهابی • دریافت هرگونه مکمل حاوی سلنیوم حداقل دو ماه قبل از مطالعه
    معیار های ورود: ابتلا به تالاسمی ماژور یا اینترمدیا عملکرد سالم کبد و کلیه معیار های خروج: نارسایی قلبی، کبدی یا کلیوی شدید سابقه ی شیمی درمانی بیماران دیابت بیماران دچار تب و عفونت های حاد و مزمن التهابی دریافت هرگونه مکمل حاوی سلنیوم حداقل دو ماه قبل از مطالعه

  • General information

    • ابتلا به تالاسمی ماژور یا اینترمدیا
    • عملکرد سالم کبد و کلیه
    ابتلا به تالاسمی ماژور یا اینترمدیا
    عملکرد سالم کبد و کلیه

  • Primary outcomes

    #1
    empty
    The antioxidant superoxide dismutase (SOD)
    empty
    آنتی اکسیدان سوپراکسید دیسموتاز (SOD)
    empty
    Start of treatment, one month after treatment
    empty
    شروع درمان، یک ماه بعد از درمان
    empty
    ELISA method is used to measure SOD
    empty
    جهت اندازه گیری SOD از روش الایزا استفاده می شود.
    #2
    empty
    Thyroid Stimulating Hormone (TSH)
    empty
    هورمون TSH
    empty
    Start of treatment, one month after treatment
    empty
    شروع درمان، یک ماه بعد از درمان
    empty
    ELISA method is used to measure TSH
    empty
    جهت اندازه گیری TSH از روش الایزا استفاده می شود.
    #3
    empty
    Triiodothyronine (T3)
    empty
    هورمون T3
    empty
    Start of treatment, one month after treatment
    empty
    شروع درمان، یک ماه بعد از درمان
    empty
    ELISA method is used to measure T3
    empty
    جهت اندازه گیری T3 از روش الایزا استفاده می شود.
    #4
    empty
    Thyroxine (T4)
    empty
    تیروکسین (T4)
    empty
    Start of treatment, one month after treatment
    empty
    شروع درمان، یک ماه بعد از درمان
    empty
    ELISA method is used to measure T4
    empty
    جهت اندازه گیری T4 از روش الایزا استفاده می شود.

  • Recruitment centers

    #1
    Name of recruitment center - English: بیمارستان بقایی 2
    Name of recruitment center - Persian: Baghaei 2 Hospital
    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: 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:

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: 2023-03-18, 1401/12/27
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
Baghaei 2 Hospital
Full name of responsible person
Kambiz Davari
Street address
Golestan Blvd-Baghaei 2 hospital
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
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
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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