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The study of effect of selenium on acute phase reactants and thyroid function test in hemodialysis patients

Protocol summary

Summary
Objectives: the aim of this study is understanding the effect of selenium on acute phase reactants and thyroid function test in hemodialysis patients. Design: randomised clinical trial. Setting and conduct: after determinding the serum level of selenium in hemodialysis patients who refferd to Emam Reza hospital, 100 patients who have selenium defficiency devided into 2 groups by age, sex and body mass index. One group treated by selenium capsule 200mg daily for 3 months and the other group treated by placebo capsule. Before and after intervention we measured ESR, CRP, FERRITIN, TSH, T4 and T3RU. Participants including major eligibility criteria: Inclusion criteria: the patient's willingness to cooperate; at least 6 months passing after dialysis starting . Exclusion criteria:infectious diseases during last 3 months; steroidal and non-steroidal anti-inflammatory drugs; vitamins E,C and zinc usage within two months before the study. Interventions: selenium capsule 200 mg daily for 3 months. Placebo capsule daily for 3 months. Main outcome measure: ESR, CRP, FERRRITIN, TSH, T4, T3RU

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041517284N1
Registration date: 2014-05-20, 1393/02/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Kanan Nikseresht
Name of organization / entity
Kermanshah University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6300
Email address
kanan-nik@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University Of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effect of selenium on acute phase reactants and thyroid function test in hemodialysis patients
Public title
The study of effect of selenium on acute phase reactants and thyroid function test in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patient's willingness to cooperate; at least 6 months passing after dialysis starting . Exclusion criteria: infectious diseases during last 3 months; steroidal and non-steroidal anti-inflammatory drugs; vitamins E, C and zinc usage within two months before the study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Not registered
Secondary trial Id
Not registered yet
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti Blvd, Vice Chancellor for Research Affairs, Kermanshah University Of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
٤٩٤٠١ شماره نامه/٤٢٠/٧/پ

Health conditions studied

1

Description of health condition studied
Hemodialysis patient
ICD-10 code
N18.0
ICD-10 code description
End-Stage renal disease

Primary outcomes

1

Description
Selenium
Timepoint
90 days
Method of measurement
By cell counter

Secondary outcomes

1

Description
Quantity CRP
Timepoint
3 months later
Method of measurement
Cell counter

2

Description
T3RU
Timepoint
3months later
Method of measurement
Cell counter

3

Description
T4
Timepoint
3months later
Method of measurement
Cell counter

4

Description
TSH
Timepoint
3months later
Method of measurement
Cell counter

5

Description
ESR
Timepoint
3months later
Method of measurement
Cell counter

6

Description
Ferritin
Timepoint
3months later
Method of measurement
Cell counter

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
Emam Reza hospital, Kermanshah
Full name of responsible person
Dr. Kanan Nikseresht
Street address
Internal ward, Emam Reza hospital, Zakaria razi Blvd.
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
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kanan Nikseresht
Position
Internal medicine resident
Other areas of specialty/work
Street address
Internal Ward, Emam Reza Hospital, Zakaria razi Blvd.
City
Kermanshah
Postal code
Phone
+98 83 1427 6300
Fax
Email
Kanan_nik@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Omrani
Position
Nephrologist
Other areas of specialty/work
Street address
Internal Ward, Emam Reza Hospital, Zakaria razi Blvd.
City
Kermanshah
Postal code
Phone
+98 83 1427 6300
Fax
Email
Hamidomrani@ymail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kanan Nikseresht
Position
Internal medicine resident
Other areas of specialty/work
Street address
Internal Ward, Emam Reza Hospital, Zakaria razi Blvd.
City
Kermanshah
Postal code
Phone
+98 83 1427 6300
Fax
Email
Kanan_nik@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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