This study is a double blind randomized controlled clinical trial and patient and physician placement of people in the placebo group and the control group is recruited patients who are also using randomization divided into two groups that the study on 50 patients with end-stage renal failure undergoing chronic hemodialysis and hemodialysis department in 1394 to visit the Imam and Razi have done so in terms of ethical considerations and informed consent.
patients in the study will be randomly by selecting a card encoded within the envelope of the package dimming by patient , will enter the group or control. Then every 3 months for patients treated with L-carnitine 500 mg 2 times a day in the control group received a placebo medication before prescribing levels of Hb, LDL and CRP were measured, then after 3 months of medication the re-measurement of the above mentioned information and statistical analysis performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112224645N2
Registration date:2015-12-24, 1394/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
hosein karimpoorian
Name of organization / entity
medical unevirsity of ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 916 603 6991
Email address
karimpoorian.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Research and Technology Development, Ahvaz University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-carnitine on oxidative stress in chronic hemodialysis patients
Public title
Effect of L-carnitine on oxidative stress in chronic hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
exclusion criteria: any acute illness of up to one month prior to the study or during the study, is leading to hospitalization؛2 patients who have known allergies to L-carnitine؛ cirrhosis of the liver or AST, LT> 45؛ Patients who are taking vitamin E or C during the study or any known antioxidant. (From 2 weeks before and 2 weeks after starting the drug L-carnitine)؛ previous failure EF <35%.
Inclusion criteria: all over 18 years and were undergoing hemodialysis three times a week for at least three months past the initiation of dialysis .
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ahvaz University of Medical Sciences, Department of Research and Technology Development
Street address
Ahvaz, City University, University of Ahvaz gondy shapoor
City
Ahvaz
Postal code
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.AJUMS.REC.1394.356
Health conditions studied
1
Description of health condition studied
Metabolic disorders
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified
Primary outcomes
1
Description
Oxidized LDL
Timepoint
Before the start of the study and 12 weeks later we measured serum levels of LDL
Method of measurement
Instrumental method based on mg / dl
Secondary outcomes
1
Description
MDA
Timepoint
Before the start of the study and 12 weeks later we measured serum levels of MDA
Method of measurement
Instrumental method based on mg /dl
Intervention groups
1
Description
Control: prescription placebo
Category
Placebo
2
Description
intervention: prescription l carnitine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Ahwaz Imam Khomeini Hospital
Full name of responsible person
shokoh shayanpoor
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellar of Ahwaz University of Medical Sciense
Full name of responsible person
Nader Saki
Street address
Ahwaz University of Medical Sciences ، University Town ، Ahwaz
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellar of Ahwaz University of Medical Sciense
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
Ahwaz University of Medical Sciences
Full name of responsible person
Shokoh shayanpoor
Position
Nephrologist
Other areas of specialty/work
Street address
Ahwaz Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3013
Fax
Email
dr.shayanpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
shokoh shayanpoor
Position
Nephrologist
Other areas of specialty/work
Street address
Golestan quarter, Ahwaz Golestan Hospital
City
Ahvaz
Postal code
Phone
+98 61 3333 3477
Fax
Email
dr.shayanpour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Karimpoorian
Position
Internal resident
Other areas of specialty/work
Street address
39, Mehr street, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
dr_hossein_k@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)