In this study, it has attempted through a study of hemodialysis patients referred to Imam Reza Hospital dialysis ward to determinate serum levels of selenium and its effects on biochemical parameters of patients to decrease the morbidity and mortality of cardiovascular diseases. . This is a double-blind clinical trial which is performed on 100 hemodialysis patients referred to Imam Reza Hospital in Kermanshah. Inclusion criteria: the patient's willingness to cooperate; at least 6 months passing after dialysis starting . Exclusion criteria:hepatitis; other infectious diseases, steroidal and non-steroidal anti-inflammatory drugs or vitamins E,C usage within two months before the study. A written agreement is obtained from hemodialysis patients to participate in this research. 3 cc fasting venous blood is taken from patients before dialysis machine is connected and after hemodialysis finishing, each patient is weighed with a light clothing using a scale with a gram accuracy and also their height is measured with a meter installed on the wall with centimeter accuracy without shoes .General characteristics of the patients are recorded on the data collection sheet. In this study, hemodialysis patients were randomly assigned to receiving selenium supplements group and placebo group. Patients in the receiving group were given selenium supplements for 3 months in form of capsule, while the placebo group received placebo capsules containing starch . On two occasions, before and 90 days after starting of study, blood samples were taken and patients are weighed at the end of the Hemodialysis session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081414333N2
Registration date:2013-09-17, 1392/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-17, 1392/06/26
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effects serum selenium on serum biomarkers in hemodialysis patients
Public title
Serum selenium and its therapeutic effects on serum biomarkers in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the patient's willingness to cooperate; at least 6 months passing after dialysis starting . Exclusion criteria: hepatitis; other infectious diseases; steroidal and non-steroidal anti-inflammatory drugs or vitamins E,C usage within two months before the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University Of Medical Sciences
City
Kermnshah
Postal code
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
646/420/7/پ
Health conditions studied
1
Description of health condition studied
hemodialysis patients
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
selenium
Timepoint
day 0,90
Method of measurement
by cell counter
2
Description
cholestrol
Timepoint
day 0 ,90
Method of measurement
by cell counter
3
Description
H.d.L.
Timepoint
day 0,90
Method of measurement
by cell counter
4
Description
L.D.L
Timepoint
day 0,90
Method of measurement
by cell counter
5
Description
serum
Timepoint
day 0,90
Method of measurement
by cell counter
6
Description
triglycerides
Timepoint
day 0,90
Method of measurement
by cell counter
Secondary outcomes
empty
Intervention groups
1
Description
daily prescription of selenium supplement for 3 months
Category
Treatment - Drugs
2
Description
daily prescription of pacebo capsule containing starch for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Emam Reza Hospital
Full name of responsible person
Dr.Kambiz Jasemi
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Kermanshah University Of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University Of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Affairs, Kermanshah University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Omrani
Position
Nephrologist
Other areas of specialty/work
Street address
Emam Reza Hospital , Dialysis Ward
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
hamidomrani@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)