Protocol summary

Summary
Introduction and Background: The incidence of atherosclerosis among hemodialysis patients is very high. A considerable proportion of hemodialysis patients lack traditional risk factors of atherosclerosis. Oxidative stress is considered a major factor in morbidity and mortality among them. Objectives: Evaluating the effects of dietary supplementation with Silymarin and/or vitamin E on oxidative stress markers, lipid profile, and hemoglobin level in hemodialysis patientsa. Design: Eighty hemodialysis patients were randomized into 4 groups: Group 1 received Silymarin 140 mg three times daily; Group 2 received Vitamin E 400 IU/day; Group 3 received Silymarin 140 mg three times daily and Vitamin E 400 IU/day; Group 4 was the control. The duration of the study was 3 weeks. Vitamin E was administered as 400 mg pills. Setting and Conduct: Samples were obtained at baseline and on day 21 for measurement of malondialdehyde (MDA), RBC glutathione peroxidase (GPX), hemoglobin and lipid profiles. Fasting blood samples (10 ml) were collected in EDTA-containing tubes from the arterial line immediately before a mid week dialysis session, before heparin administration, and immediately before supplementation (baseline) and on day 21 after the intervention period. Samples were immediately centrifuged and frozen at −70°C. Participants including major eligibility criteria: Subjects were recruited from among clinically stable hemodialysis patients (age range 18–60 years) in Ebrahimi Hemodialysis Center in Sadra City (Shiraz, Iran). All patients received four hour hemodialysis treatments, three times per week. The membrane and the general dialysis prescription were similar for all patients. Exclusion criteria consisted of history of a cardiovascular event within the previous 12 months, use of cholesterol-lowering agents (statins), Omega-3, Vitamin E, levothyroxin, and oral contraceptives. Patients with any active infection including hepatitis B or C, New York Heart Association class III and IV heart failure were also excluded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904234376N1
Registration date: 2010-08-24, 1389/06/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-08-24, 1389/06/02
Registrant information
Name
Bahram Shahriyari
Name of organization / entity
Shiraz Nephro-Urology Research Centre(SNURC)
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 1086
Email address
shahriyari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study was financially supported by Office of Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2009-11-03, 1388/08/12
Expected recruitment end date
2010-03-11, 1388/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effects of Silymarin and Vitamin E Supplementation on Oxidative Stress Markers, Lipid Profiles and Hemoglobin Level in Hemodialysis Patients
Public title
Evaluation of the Effect of Silymarin, an Antioxidant, on Oxidative Stress Markers in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Clinically stable patients within the age range of 18-60. Undergoing maintenance hemodialysis initiated >=3 months previously at a rate of 3 times per week, each session 4 hours. Exclusion criteria: History of cardiovascular event within the previous 12 months, use of cholestrol-lowering agents(statins), Omega-3, Vitamin E, Levothyroxin, and oral contraceptive pills (OCP), infections including HBV, HCV, heart failure class III and IV according to New York Heart Association(NYHA) were also excluded.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

1

Registry name
Clinicaltrials.gov
Secondary trial Id
NCT01001845
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand street-Central Building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
1978-71345
Approval date
2009-12-11, 1388/09/20
Ethics committee reference number
ct-88-4821

Health conditions studied

1

Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease

Primary outcomes

1

Description
Hemoglobin level
Timepoint
21 days
Method of measurement
Sampling and Biochemical Analysis

2

Description
Oxidative Stress Markers level
Timepoint
21 days
Method of measurement
Sampling and Biochemical Analysis

Secondary outcomes

empty

Intervention groups

1

Description
Silymarin and Vitamin E
Category
Treatment - Drugs

2

Description
Control: No study related intervention
Category
N/A

3

Description
Silymarin
Category
Treatment - Drugs

4

Description
Vitamin E
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Haj Ebrahimi dialysis centre-sadra
Full name of responsible person
Bahram Shahriyari
Street address
Haj Ebrahimi Dialysis Centre - Sadra City
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mohammad Hossein Dabaghmanesh
Full name of responsible person
Office of Vice Chancellor-Shiraz University of Medical Sciences
Street address
Central building of shiraz university of medical sciences-Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohammad Hossein Dabaghmanesh
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
Shiraz Nephrology-Urology Research Centre
Full name of responsible person
Bahram Shahriyari
Position
Internist and fellow of Nephrology
Other areas of specialty/work
Street address
3rd floor, Faghihi Hospital Emergency room Building, Zand street
City
Shiraz
Postal code
7134844119
Phone
+98 71 1235 1086
Fax
+98 71 1235 6400
Email
shahriyari@sums.ac.ir
Web page address
http://www.snurc.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Nephro-Urology Research Centre
Full name of responsible person
Jamshid Roozbeh
Position
Associate Professor of Nephrology
Other areas of specialty/work
Street address
3rd floor, Faghihi Hospital Emergency room Building, Zand street
City
Shiraz
Postal code
7134544119
Phone
+98 71 1235 1086
Fax
+98 71 1235 6400
Email
snurc@sums.ac.ir
Web page address
http://www.snurc.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Nephro-Urology Resarch Centre
Full name of responsible person
Bahram Shahriyari
Position
Internist and Fellow of Nephrology
Other areas of specialty/work
Street address
3rd floor, Faghihi Hospital Emergency room Building, Zand street
City
Shiraz
Postal code
7134544119
Phone
+98 71 1235 1086
Fax
+98 71 1235 6400
Email
shahriyari@sums.ac.ir
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
Loading...