This study is a randomized, clinical trial. Study group include patients with chronic kidney disease with age between 20-65 years that visited in Tooba Nephrlogy clinic.These patients divide into 3 subgroups (with 15 patients in each subgroup) as creatinine clearance.1) Subgroup with creatinine clearance between 60-89 ml/min (mild CKD). 2) Subgroup with creatinine clearance between 30-59 ml/min (moderate CKD).3) Subgroup with creatinine clearance less than 30 ml/min (sever CKD). First, selenium plasma level and glutathione peroxidase enzyme activity are measured in all patients as baseline.Then, a 200 microgram selenium tablet (Nature Made product, made in USA) is administered daily to each patient in all 3 subgroups in fasting state.After 3 months, selenium plasma level and glutathione peroxidase enzyme activity are measured in all patients and will compared with baseline data by statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305318501N2
Registration date:2013-06-29, 1392/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-29, 1392/04/08
Registrant information
Name
Omid Sedighi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 7230
Email address
osedighi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of selenium supplementation on glutathione peroxidase enzyme activity in patients with chronic kidney disease
Public title
Effect of selenium supplementation on glutathione peroxidase enzyme activity in patients with chronic kidney disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Patient with chronic kidney disease for ≥ 3 month
2) patients≥ 20 years and<65 years3) Plasma albumin level 4 g/dl
Exclusion criteria:1) Acute infection 2) Recent acute myocardial infarction during 6 week ago 3) Recent consumption of antioxidant drugs (for example vitamine A, E, C) 4) Active smoking 5) History of new or old cancer 6)Liver failure
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Mazandaran University of Medical Sciences
Street address
Department of Research and Technology, Moallem Square
City
Sari
Postal code
Approval date
2012-12-19, 1391/09/29
Ethics committee reference number
91-154
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
glutathione peroxidase enzyme activity
Timepoint
Before study, Three months after drug supplementation
Method of measurement
ELISA (Kit made by UK)
Secondary outcomes
1
Description
selenium plasma level
Timepoint
Before study, Three months after drug supplementation