Protocol summary
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Study aim
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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.
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Design
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Randomized 42 patients were studied. The sampling method will be both before and after supplemental therapy and fasting.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Determination of levels of IL-6, IL-1b, IL-2, TNF-a, CRP, neutrophil to lymphocyte ratio (N/L Ratio)
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2023-02-06, 1401/11/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-21, 1401/12/02
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Expected recruitment end date
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2023-06-21, 1402/03/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of supplementation with Selenium on serum inflammatory factors of beta thalassemia major patients.
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Public title
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Investigation of the effect of Selenium in beta thalassemia major
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
42
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-14, 1401/08/23
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Ethics committee reference number
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IR.AJUMS.HGOLESTAN.REC.1401.140
Health conditions studied
1
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Description of health condition studied
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thalassemia major
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ICD-10 code
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D56.1
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ICD-10 code description
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Beta thalassemia
Primary outcomes
1
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Description
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TNF-alpha (TNF-a)
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure TNF-a.
2
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Description
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IL-6
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure IL-6.
3
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Description
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IL-1b
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure IL-1b.
4
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Description
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IL-2
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure IL-2.
5
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Description
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C-reactive protein (CRP)
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure CRP.
6
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Description
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Neutrophil to lymphocyte ratio (N/L Ratio)
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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The ratio of neutrophils to lymphocytes (N/L ratio) is obtained from the results of complete blood count (CBC).
7
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Description
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The antioxidant superoxide dismutase (SOD)
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure SOD
8
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Description
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Thyroid Stimulating Hormone (TSH)
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure TSH
9
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Description
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Triiodothyronine (T3)
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure T3
10
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Description
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Thyroxine (T4)
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Timepoint
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Start of treatment, one month after treatment
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Method of measurement
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ELISA method is used to measure T4
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available