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Effects of alpha lipoic acid supplementation on serum level of visfatin, markers of oxidative stress, inflammation and insulin resistance in patients with chronic renal failure undergoing hemodialysis.

Protocol summary

Summary
The main purpose of this study is to evaluate the effects of alpha lipoic acid supplementation on serum level of visfatin, markers of oxidative stress, inflammation, and insulin resistance in patients with chronic renal failure undergoing hemodialysis. 60 patients with ESRD who are on hemodialysis for more than 6 months and receive 3 times hemodialysis each week will be included in this study and randomly assigned into the treatment group receiving 600 mg/day of alpha lipoic acid for 8 weeks, or the control group receiving placebo. 24 hrs recalls for 2 days (dialysis and non dialysis day) will be recorded at the baseline and after 8 weeks. Fasting blood samples will be obtained at the baseline and after 8 weeks. Cholesterol, TG, HDL, FBS, and TAC measured by calorimetric method, Visfatin, insulin measured by ELIZA, hsCRP measured by immunoturbidometric method, and MDA measured by flurimetric method in serum will be measured and compared between groups. HOMA-IR will be calculated by formula and LDL by Fridewald formula.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138806301197N2
Registration date: 2010-03-20, 1388/12/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-03-20, 1388/12/29
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; Vice Chancellor for Research, Tabriz University Of Medical Sciences; Drug Applied 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 serum level of visfatin, markers of oxidative stress, inflammation and insulin resistance in patients with chronic renal failure undergoing hemodialysis.
Public title
Effects of alpha lipoic acid supplementation on serum level of visfatin, markers of oxidative stress, inflammation and insulin resistance in patients with chronic renal failure undergoing hemodialysis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obtaining informed consent, being on hemodialysis for more than 6 months, receiving 3 times hemodialysis each week Exclusion criteria: hepatitis and other infections less than 20 years, receiving any NSAID and SAID, alpha lipoic acid supplement, vitamin C, vitamin E, valporic acid in the month prior to the study, presence of gastrointestinal disorders, being candidate for kidney transplantation, pregnancy or lactation, smoking, possibility of any side effect for consumption of the supplement
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease

Primary outcomes

1

Description
visfatin
Timepoint
baseline and after 8 weeks
Method of measurement
ELIZA

2

Description
TAC
Timepoint
baseline and after 8 weeks
Method of measurement
calorimetric method

3

Description
MDA
Timepoint
baseline and after 8 weeks
Method of measurement
flurimetric method

4

Description
hsCRP
Timepoint
baseline and after 8 weeks
Method of measurement
immunoturbidometric method

5

Description
fasting insulin
Timepoint
baseline and after 8 weeks
Method of measurement
ELIZA

6

Description
fasting Glu
Timepoint
baseline and after 8 weeks
Method of measurement
calorimetric method

7

Description
HOMA-IR
Timepoint
baseline and after 8 weeks
Method of measurement
formula

8

Description
Tchol
Timepoint
baseline and after 8 weeks
Method of measurement
calorimetric method

9

Description
serum TG
Timepoint
baseline and after 8 weeks
Method of measurement
calorimetric method

10

Description
serum HDL-c
Timepoint
baseline and after 8 weeks
Method of measurement
calorimetric method

11

Description
serum LDL
Timepoint
baseline and after 8 weeks
Method of measurement
Friedelwald formula

12

Description
Body Mass Index (BMI)
Timepoint
baseline and after 8 weeks
Method of measurement
calculation

13

Description
Total Daily Calorie
Timepoint
baseline and after 8 weeks
Method of measurement
24h recalls

14

Description
Daily protein
Timepoint
baseline and after 8 weeks
Method of measurement
24h recalls

15

Description
Daily Fat
Timepoint
baseline and after 8 weeks
Method of measurement
24h recall

16

Description
Daily charbohydrate
Timepoint
baseline and after 8 weeks
Method of measurement
24h recall

17

Description
Update 19 Feb 2011: serum albomin
Timepoint
Update 19 Feb 2011: baseline and after 8 weeks
Method of measurement
Update 19 Feb 2011: Bromocresol Green method

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
empty

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
Reza Mahdavi
Street address
Tabriz University Of Medical Science
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nutritional Research Center Tabriz University Of Medical Science
Full name of responsible person
Ali Reza Ostadrahimi
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 Science
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University Of Medical Science
Full name of responsible person
Ali Reza Ostadrahimi
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
Vice Chancellor for Research, Tabriz University Of Medical Science
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
Drug Applied Research Center Tabriz University Of Medical Sciences
Full name of responsible person
Hossein Babaei
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
Drug Applied Research Center Tabriz University Of Medical Sciences
Proportion provided by this source
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)
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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