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Investigation of the effect of selenium on thyroid function test in hemodialysis patients

Protocol summary

Study aim
1. Comparison of serum selenium levels before and after treatment with selenium in hemodialysis patients. 2-Comparison of serum selenium levels before and after treatment with selenium in hemodialysis patients.
Design
Clinical trial with control group, with parallel, two-way blind, randomized, phase 3 pharmacological study on 66 hemodialysis patients, enrolled between May 2020 to August 2020 . Includes 33 patients in the case group and 33 patients in the control group who were randomly assigned to these two groups. Randomization is done by a table of random numbers.
Settings and conduct
This clinical trial will be performed in hemodialysis centers of Ali Ibn Abitaleb Hospital in Zahedan . Patients will be screened for entry and exit conditions. Patients who volunteer will be included in the study. The serum sample will be taken before receiving the drug and then stored in the refrigerator at -70 degrees. Patients, nurses, drug dealers, and data analysts are blind to the case group. The researcher will personally place patients in the control group or control group through a table of random numbers. The contents of the medicine will be coded by the researcher and others will be unaware of the type of medicine. Patients will receive medication for 12 weeks. After 12 weeks, the final blood sample will be taken.
Participants/Inclusion and exclusion criteria
Participants: All hemodialysis patients Inclusion criteria: The duration of hemodialysis is more than 6 months. Exclusion criteria: Dissatisfaction of the patient, concomitant use of antioxidants at the time of entry into the study, suffering from cancer, any infection during the study, thyroid disease requiring treatment.
Intervention groups
Case group: Treatment with selenium group for 3 months. Control group:Treatment with placebo for 3months.
Main outcome variables
changes:free T3, freeT4, TSH, rT3, Selenium

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200502047270N1
Registration date: 2020-07-04, 1399/04/14
Registration timing: registered_while_recruiting

Last update: 2020-07-04, 1399/04/14
Update count: 0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
Zahra Adineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 5279
Email address
drzahraadineh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of selenium on thyroid function test in hemodialysis patients
Public title
Evaluation of selenium effect on thyroid function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis duration more than 6 months
Exclusion criteria:
Sensitivity to selenium Selenium consumption over the past 3 months Thyroid disease needs treatment
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization All eligible hemodialysis patients, if desired, entered the study through a table of random numbers and were placed in two groups of case and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher personally puts the drug or placebo in the package and set the patients in the case or control group according to the table of random numbers and numbers the package related to each patient and the others are blind to the type of packaged content. Other people, such as the clinical caregiver and drug distributor and data analyzer, know the groups only on the A and B levels and are blind to the case or control of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Investigation of the effect of selenium on thyroid function in hemodialysis patients

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Ali Ibn Abotaleb ,Khalije fars Boulv.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817958569
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.ZAUMS.REC.1398.249

Health conditions studied

1

Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease

Primary outcomes

1

Description
Changes in serum free T4
Timepoint
At the beginning of the intervention and 12 weeks after the start of the intervention
Method of measurement
Chemi Luminescence

2

Description
Changes in serum free T4
Timepoint
At the beginning of the intervention and 12 weeks after the start of the intervention
Method of measurement
Chemi Luminescence

3

Description
Changes in TSH level
Timepoint
At the beginning of the intervention and 12 weeks after the start of the intervention
Method of measurement
Chemi Luminescence

4

Description
Changes in rT3 level
Timepoint
At the beginning of the intervention and 12 weeks after the start of the intervention
Method of measurement
Chemi Luminescence

5

Description
Changes in Selenium level
Timepoint
At the beginning of the intervention and 12 weeks after the start of the intervention
Method of measurement
atomic absorption spectrophotometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Selenium 200 mg receiving group as oral capsule from 20th Century Pharmaceutical Company for 3 months daily capsule version
Category
Treatment - Drugs

2

Description
Control group: The control group receives the placebo as an oral capsule of exactly the same shape and color of the main drug made by the pharmacy of the research center of the relevant university containing starch for 3 months daily.main drug
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ibn Abitaleb hospital
Full name of responsible person
Zahra Adineh
Street address
Khalige fars Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817958569
Phone
+98 54 3328 5279
Email
drzahraadineh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sharaki
Street address
Dctor Heasabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
981079508569
Phone
+98 54 3328 5279
Email
drzahraadineh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Adineh
Position
Resident assisstant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali Ibn Abitaleb hospital, Khalige fars Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817958569
Phone
+98 54 3328 5279
Email
drzahraadineh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Adineh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali Ibn Abitaleb hospital, Kalige Fars Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817958569
Phone
+98 54 3328 5279
Email
drzahraadineh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Adineh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali Ibn Abitaleb hospital, Kalige Fars Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817958569
Phone
+98 54 3328 5279
Email
drzahraadineh@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
Data on the main implications of the study will be made available to scientific and service organizations and institutions in a report six months after the end of the intervention.
When the data will become available and for how long
six months after the end of the intervention
To whom data/document is available
All applicants
Under which criteria data/document could be used
The data are available for scientific and academic reasoning and for researchers to investigate similar interventions. The only condition for access is the confidentiality of patient information.
From where data/document is obtainable
Dr. Zahra Adineh By email drzahraadineh@gmail.com
What processes are involved for a request to access data/document
Request via email and state the reason for the request.
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