Determining the mean weight change, changing the lipid profile and changing the physical activity in hemodialysis patients before and after receiving selenium, as well as before and after placebo in the control group
Design
This is a double-blind clinical trial and 90 patients with selenium-deficient hemodialysis are non randomly divided into case and control groups.
Settings and conduct
This study will be done performed on hemodialysis patients referring to dialysis centers affiliated to Isfahan University of Medical Sciences. At the beginning of the project, 3 cc of venous blood will be taken from all patients, and then Serum levels of selenium will checked. After hemodialysis, the weight of each patient will be measured, the level of lipid profiles and the level of activity of individuals (by five times sit to stand test) will be calculated and recorded. Participants will be treated with medication and placebo for 3 months and after that serum levels of selenium, weight gain, lipid profile and physical activity of individuals will be recalculated and recorded again.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are the serum levels of selenium lower than normal, the patient's willingness to co-operate and pass at least 6 months after the onset of hemodialysis; Exit criteria include hepatitis, normal serum levels of selenium, skeletal disorders, and the use of steroid and non-steroidal anti-inflammatory drugs within two months before the start of the study.
Intervention groups
Individuals in two groups of 1 and 2 are non randomly divided and a group treated with 2 pills of selenium (200 μg) after each dialysis (3 times a week) and the other group treated with two pill of the placebo after each dialysis dose (3 times a week).
Effect of selenium on lipid profile, Weight gain and Physical Activity in hemodialysis patients
Public title
Effect of selenium on lipid profile, Weight gain and Physical Activity in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months passing after hemodialysis starting
The patient's willingness to cooperate
Exclusion criteria:
Hepatitis
Skeletal disorder
Steroidal and non-steroidal anti-inflammatory drugs within two months before the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants are divided into two groups: 1 and 2, One group of medicines and another group receive placebo. Neither the participants nor the investigators know which drug and which placebo are
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-04-11, 1398/01/22
Ethics committee reference number
IR.MUI.MED.REC.1398.006
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum triglyceride levels
Timepoint
Before starting the study and 3 months after the intervention began
Method of measurement
Autoanalyser
2
Description
Total serum cholesterol level
Timepoint
Before starting the study and 3 months after the intervention began
Method of measurement
Autoanalyser
3
Description
Weighing
Timepoint
Before starting the study and 3 months after the intervention began
Method of measurement
Scale
4
Description
Physical activity
Timepoint
Before starting the study and 3 months after the intervention began
Method of measurement
Five times sit to stand test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 selenium pills (200 micrograms) from Webber Naturals Canada after each hemodialysis (3 times a week) for 3 months
Category
Treatment - Drugs
2
Description
Control group: 2 Placebo (Starch) tablets after each hemodialysis (three times a week) for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Unit of Al-Zahra Hospital
Full name of responsible person
Hamed Mohamadian Shoeili
Street address
Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 3668 5555
Email
hamed_23msh@yahoo.com
Web page address
http://alzahra.mui.ac.ir/
2
Recruitment center
Name of recruitment center
Hemodialysis Unit of the Khorshid Hospital
Full name of responsible person
Hamed Mohamadian Shoeili
Street address
Ostandari Street
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
hamed_23msh@yahoo.com
Web page address
http://nour.mui.ac.ir/
3
Recruitment center
Name of recruitment center
Hemodialysis Unit of Amin Hospital
Full name of responsible person
Hamed Mohamadian Shoeili
Street address
Ibn Sina Street
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3303 3400
Email
hamed_23msh@yahoo.com
Web page address
https://amin.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjuy Javanmard
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamed Mohamadian Shoeili
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Nephrology
Street address
Isfahan Medical Faculty, Hezarjarib St, Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
hamed429@resident.mui.ac.ir
Web page address
http://med.mui.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Abdolamir Atapour
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Khorshid Hospital, Ostandary Street
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
atapour@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamed Mohamadian Shoeili
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan Medical Faculty, Hezarjarib St, Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
hamed429@resident.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the clinical study Will be published as a paper.
When the data will become available and for how long
After giving out the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific use with reference to article
From where data/document is obtainable
hamed429@resident.mui.ac.ir
What processes are involved for a request to access data/document