Cardiovascular diseases are the most common causes of mortality among CKD patients.
This is essentially due to chronic inflammation. Alpha lipoic acid ( ALA ) is a potential anti-inflammatory agents and may have some benefits in dialytic patients. Our study is a double blind randomized clinical trial on 60 ESRD patients in Tabriz city That divided to 2 groups(each group 30 patients ) that receive 800 mg ALA or placebo orally for 60 consecutive days respectively. Serum TNF-α and IL-8 level would been measured in the beginning and after 60 days of trial and analyzed by proper analytic methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051813360N1
Registration date:2013-06-07, 1392/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-07, 1392/03/17
Registrant information
Name
Javid Safa
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4652
Email address
drsafa2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Chronic Kidney Diseases research center, Tabriz University of Medical Sciences
Expected recruitment start date
2013-06-01, 1392/03/11
Expected recruitment end date
2013-08-10, 1392/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Alpha-Lipoic Acid Supplementation
on sreum TNF alpha and IL-8 in hemodialytic patients.
Public title
Antioxidant effects of alpha lipoic acid on dialytic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: 1-acceptance and compliance of patients 2- history of 6 months hemodialysis or more 3- 3 session of hemodialysis every week
Exclusion:1- hepatitis B and any active infection 2-Age<20 3-non steroid anti-inflammatory drugs, steroid,Vitamin-C, Vit E, Valproat Na use 4- Smoking 5- Advers reaction and sensitivity to alpha lipoic acid 6- Gastrointestinal disorders 7- pregnancy and breast feeding 8- candidates for recent kidney trancplantation (less than 1 month )
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:
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
Tabriz University of Medical Sciences
Street address
Daneshgah Avenue
City
Tabriz
Postal code
Approval date
2013-05-20, 1392/02/30
Ethics committee reference number
9230
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5 on dialysis
Primary outcomes
1
Description
interleukin-8
Timepoint
Time zero and 60 days after intervention
Method of measurement
ELISA kit
2
Description
TNF-alpha
Timepoint
Time zero and 60 days after intervention
Method of measurement
ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
administration of 600 mg alpha lipoic acid capsule orally for 60 consecutive days.
Category
Treatment - Other
2
Description
administration of placebo capsules orally for 60 consecutive days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
29 Bahman hospital
Full name of responsible person
Mrs. Roghayeh Mosleh manager of dialysis ward
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Sina general hospital
Full name of responsible person
Street address
City
Tabriz
3
Recruitment center
Name of recruitment center
Shahid madany hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Ardalan Chief of chronic kidney diseases research center
Street address
Imam Reza hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Javid Safa
Position
Assisstant professor of nephrology
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1334 4339
Fax
Email
drsafa2003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javid Safa
Position
Assisstant professor of nephrology
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1334 4339
Fax
Email
drsafa2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Pourkar Jadid
Position
MD, Internal medicine resident
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Tabriz
Postal code
Phone
Fax
Email
maryampoorkarjadid@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)