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Evaluation of the effect of Alfa lipoic acid, Vitamin E supplementation and their combination on oxidative stress, lipid profile, insulin resistance, inflammation and nutritional status in patients on hemodialysis, Shiraz, 2010

Protocol summary

Summary
To evaluate the effect of Vitamin E, lipoic acid (LA) and their combination on long term complications in patients on hemodialysis, 96 hemodialysis patients, aged 20-60 years old, were recruited from Sadra and Namazi dialysis centers in Shiraz, Iran. The patients were randomly assigned into the following 4 groups, based on the block randomization protocol, to receive 600 mg LA, 400IU Vitamin E, 600mg LA+400IU Vitamin E, daily, or placebo for 2 months. Primary outcome of this study is evaluation of oxidative stress through measurement of hs-CRP, MDA, and IL6.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201103156072N1
Registration date: 2011-04-15, 1390/01/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-15, 1390/01/26
Registrant information
Name
Afsaneh Ahmadi
Name of organization / entity
School of health and nutrition, Shiraz University of Mediccal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1227 4072
Email address
ahmadi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-01-10, 1389/10/20
Expected recruitment end date
2011-03-01, 1389/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Evaluation of the effect of Alfa lipoic acid, Vitamin E supplementation and their combination on oxidative stress, lipid profile, insulin resistance, inflammation and nutritional status in patients on hemodialysis, Shiraz, 2010
Public title
Evaluation of the effect of Alfa lipoic acid, Vitamin E supplementation and their combination on long term complications in patients on hemodialysis, Shiraz, 2010
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 20-60 years, hemodialysis, twice a week, undergoing maintenance hemodialysis for more than 1 year, no receiving antioxidant supplements such as VitE, VitC, or fish oil Exclusion criteria: smoking, pregnancy, presence of acute inflammatory and infectious diseases, presence of liver or Rheumatic diseases (such as lupus,...), cardiac diseases, or cancer, use of anticoagulants or contraceptives thyroxin
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2011-01-06, 1389/10/16
Ethics committee reference number
89-5408

Health conditions studied

1

Description of health condition studied
End stage of renal disease (hemodialysis)
ICD-10 code
N18
ICD-10 code description
Chronic renal failure

Primary outcomes

1

Description
hs-CRP
Timepoint
Before and 2 months after intervention
Method of measurement
ELISA kit

2

Description
malon-dialdehide (MDA)
Timepoint
Before and 2 months after intervention
Method of measurement
Spectrophotometry

3

Description
Interlukin-6 (IL6)
Timepoint
Before and 2 months after intervention
Method of measurement
RIA

Secondary outcomes

1

Description
insulin
Timepoint
Before and 2 months after intervention
Method of measurement
ELISA kit

2

Description
lipid profile
Timepoint
Before and 2 months after intervention
Method of measurement
Auto analyser

3

Description
FBS
Timepoint
Before and 2 months after intervention
Method of measurement
Auto analyser

Intervention groups

1

Description
alpha-lipoic acid intake ,600mg per day, for 2 months
Category
Treatment - Drugs

2

Description
Vitamin E intake, 400IU per day ,for 2 months
Category
Treatment - Drugs

3

Description
alph-lipoic acid 600mg+VitaminE400IU, per day,for 2 months
Category
Treatment - Drugs

4

Description
placebo intake for 2 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sadra Hemodialysis Center
Full name of responsible person
Street address
City
Shiraz

2

Recruitment center
Name of recruitment center
Namazi Hemodialysis Center
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afsaneh Ahmadi
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
School of Health And Nutrition, Shiraz University of Mediccal Sciences
Full name of responsible person
Negin Mazouji
Position
MSc. student of nutrition
Other areas of specialty/work
Street address
Department of Nutrition, School of Health and Nutrition, Shiraz University of Mediccal Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1001
Fax
Email
negin.mazouji@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health and Nutrition, Shiraz University of Mediccal Sciences
Full name of responsible person
Afsaneh Ahmadi
Position
Nutrition MSc- Lecturer
Other areas of specialty/work
Street address
Department of Nutrition, School of Health and Nutrition, Shiraz University of Mediccal Sciences
City
shiraz
Postal code
7153675541
Phone
+98 71 1725 1001
Fax
Email
ahmadi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Health and Nutrition, Shiraz Universoty of Medical Sciences
Full name of responsible person
Negin Mazouji
Position
MSc. nutrition student
Other areas of specialty/work
Street address
Departeman of Nutrition, School of Health and Nutrition , Shiraz Universoty of Medical Sciences,Shiraz
City
Shiraz
Postal code
Phone
Fax
Email
Web page address

Sharing plan

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