Evaluation of the efficacy of Selenium supplementation therapy on the inflammatory markers oxidative stress and liver functional parameters in thalassemia major and intermediate
Evaluation of the efficacy of Selenium supplementation therapy on the inflammatory markers oxidative stress and liver functional parameters in thalassemia major and intermediate e in Zanjan province.
Design
The clinical trial has a community-based, practice-oriented one group, with group only
Settings and conduct
Eligible patients who have referred to the blood clinic of Ayatollah Mousavi Hospital in Zanjan will be included in the study. In these patients, in addition to routine treatments, they will take 200 micrograms of selenium tablets daily for 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Willingness to participate in the study 2. Having thalassemia major or intermedia 2. Having healthy liver and kidney function
Exclusion criteria:
1. History of chemotherapy 2. Take any supplements and vitamins at least two months before the study 3. Diabetic patients 4. Patients with acute and chronic infections 5. Having any inflammatory disease
Intervention groups
A group will participate in this study. In addition to routine treatments, this group will take 200 micrograms of selenium tablets daily for 4 weeks.
Main outcome variables
Decreased inflammatory markers (ferritin and hCRP), Decreased liver function parameters (AST and ALT), Reduction of oxidative stress markers (Malondialdehyde)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210326050772N1
Registration date:2021-09-13, 1400/06/22
Registration timing:prospective
Last update:2021-09-13, 1400/06/22
Update count:0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Narges Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 9604
Email address
narges.heidari90@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Selenium supplementation therapy on the inflammatory markers oxidative stress and liver functional parameters in thalassemia major and intermediate
Public title
Evaluation of the efficacy of Selenium supplementation therapy on the inflammatory markers oxidative stress and liver functional parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Having thalassemia major or intermedia
Having healthy liver and kidney function
Exclusion criteria:
History of chemotherapy
Take any supplements and vitamins at least two months before the study
Diabetic patients
Patients with acute and chronic infections
Having any inflammatory disease
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Deputy of Research and Technology of Zanjan University of Medical Sciences
Street address
Deputy of Research and Technology, third floor, Second building, Central Headquarters of Zanjan University of Medical Sciences, The beginning of Jomhuri Eslami Boulevard, Azadi Blv, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.ZUMS.REC.1399.250
Health conditions studied
1
Description of health condition studied
Thalassemia major and intermedia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Inflammatory markers
Timepoint
Before the intervention and 30 days after the start of selenium consumption
Method of measurement
By measuring the inflammatory markers hCRP and ferritin
2
Description
Oxidative stress marker (Malondialdehyde)
Timepoint
Before the intervention and 30 days after the start of selenium consumption
Method of measurement
By measuring the oxidative stress markers (Malondialdehyde)
3
Description
Liver function parameters
Timepoint
Before the intervention and 30 days after the start of selenium consumption
Method of measurement
By measuring the liver function parameters (AST and ALT)
Secondary outcomes
empty
Intervention groups
1
Description
In these patients, in addition to routine treatments, they will take 200 micrograms of selenium tablets daily for 30 days.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan and Al-Ghadir Abhar Hospital
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
Undecided - It is not yet known if there will be 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
After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary).
When the data will become available and for how long
The start of the access period to the data of this study will be from Early 2022 and approximately 6 months after the publication of the results.
To whom data/document is available
The data of this study are possible for all patients with thalassemia major and intermedia, and especially those working in health care systems.
Under which criteria data/document could be used
The researcher wants to use the data to improve major and intermedia Thalassemia.
From where data/document is obtainable
To receive information anyone can be use the following email: Kddavari@zums.ac.ir, soltanpoorm@zums.ac.ir
What processes are involved for a request to access data/document
After sending the message and introducing herself or himself and the reason for the need for data, the applicant will be provided with the information after confirmation.