Effects of alpha lipoic acid supplementation on some antioxidant defence system indices in patients with chronic renal failure undergoing hemodialysis.
The main purpose of this study is to evaluate the effects of alpha lipoic acid supplementation on some antioxidant defense system indices in patients with chronic renal failure undergoing hemodialysis. A total of 63 patients with ESRD on HD (hemodialysis) for more than 6 months, receiving 3 times dialysis in a week, will be included in this study. The patients are randomly assigned into treatment group, receiving 600 mg/day of alpha lipoic acid for 8 week, or control group receiving placebo. Fasting blood samples will be taken at the baseline and after 8 weeks. Superoxide dismutase, glutathione peroxidase, catalase, and hemoglobin will be measured by spectrophotometric method in blood samples.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902041197N4
Registration date:2010-11-20, 1389/08/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-20, 1389/08/29
Registrant information
Name
Reza Mahdavi
Name of organization / entity
Faculty of Health & Nutrition, Tabriz UniV. of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7584
Email address
mahdavir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Research Center, Tabriz University Of Medical Sciences
Expected recruitment start date
2010-01-20, 1388/10/30
Expected recruitment end date
2010-04-19, 1389/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of alpha lipoic acid supplementation on some antioxidant defence system indices in patients with chronic renal failure undergoing hemodialysis.
Public title
Effects of alpha lipoic acid supplementation on some antioxidant defence system indices in patients with chronic renal failure undergoing hemodialysis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obtaining informed consent, being on HD for more than 6 months receiving 3 dialysis in week
Exclusion criteria: hepatitis and other infections, age less than 20 years, receiving any NSAID and SAID, alpha lipoic acid supplement, vitamin C , vitamin E, valproic acid in the last month, gastrointestinal disorders, candidate for kidney displacement, pregnancy, lactation, smoking, presence of any side effect
Age
From 20 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2009-10-05, 1388/07/13
Ethics committee reference number
886
Health conditions studied
1
Description of health condition studied
Chronic renal failure undergoing hemodialysis
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
SOD
Timepoint
baseline and after 8 weeks
Method of measurement
Specrophotometery
2
Description
GPx
Timepoint
baseline and after 8 weeks
Method of measurement
Specrophotometery
3
Description
catalase
Timepoint
baseline and after 8 weeks
Method of measurement
Specrophotometery
4
Description
Hb
Timepoint
baseline and after 8 weeks
Method of measurement
Specrophotometery
Secondary outcomes
1
Description
health benefits for patients
Timepoint
baseline and weekly monitoring
Method of measurement
observation and evaluation of biochemical parameters
Intervention groups
1
Description
Daily consumption of alpha lipoic acid capsule (600 mg) for 8 weeks
Category
Treatment - Drugs
2
Description
Daily consumption of placebo for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis centers in Tabriz
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Research Center Tabriz University Of Medical Sciences
Full name of responsible person
Ali Reza Ostad Rahimi
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional Research Center Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Reza Mahdavi
Position
Associate professor
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
mahdavir@tbzmed.ac.ir t.khabbazi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Tannaz Khabbazi
Position
MS student of Nutrition
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
t.khabbazi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Tannaz Khabbazi
Position
MS student of Nutrition
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
t.khabbazi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)