Chronic renal failure is a pathological process with multiple causes. More than a million people die annually due to the end stage renal disease. The most important cause of mortality in ESRD and hemodialysis patients is cardio vascular disease. Common causes to some extent higher risk factor for cardiovascular disease in hemodialysis patients. Several cytokines and hormones (so called adiponectin) are secreted from fat tissue, TNF, leptin, adiponectin, visfatin. resistin..The level of leptin is increased in ESRD and hemodialysis patients. Chronic hemodialysis (HD) frequently encounter carnitin depletion Carnitin has anti-inflammatory and anti-oxidant properties.person who are enrolled must be over 21 years old and they have passed one year of dialysis .50 hemodialysis patients from dialysis centers allocate and divide in to groups.1-intervention group :they receive 1 gram of carntine daily for 3 month ,2-control group : they do not receive supplement.level of leptin ,adiponectin and TAC are measured at the beginning and the end of study.The aim of study is evaluate the effect of carnitin supplementation on level of leptin and adiponectin and TAC in hemodialysis patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070913160N2
Registration date:2013-11-06, 1392/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-06, 1392/08/15
Registrant information
Name
Shima Dehghan
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 5453
Email address
sh.dehghan@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deparment of Nutrition, Departmen of Public Health, Yazd University of Medical Sciences
Expected recruitment start date
2013-10-06, 1392/07/14
Expected recruitment end date
2013-11-07, 1392/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of carnitine supplementation on adiponectin and leptin total antioxidant capacity concentrations in hemodialysis patients
Public title
The effect of carnitin supplementation in hemodialysis patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: patients on hemodialysis in last year; age older than 21 years old and did not take antibiotics; vitamin C, vitamin E, carnitine during last 8 weeks. Exclusion criteria: if a patients suffering from an infection diease or fever in last month or is taking antibiotics.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
yazd, Bahonar squar, Centeral organization of Yazd University of Medical Sciences
City
Yazd
Postal code
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
52310
Health conditions studied
1
Description of health condition studied
Hemodilysis
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
Leptin
Timepoint
Baseline, end of thirth month
Method of measurement
ELISA
2
Description
Adiponectin
Timepoint
Baseline, end of thirth month
Method of measurement
ELISA
3
Description
Total anti oxidant capicity
Timepoint
Baseline, end of thirth month
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: take 1 gram L carnitin syroup for 3 months.
Category
Treatment - Drugs
2
Description
Control group: patients do not recieve carnitin supplement or drug.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayed Shohada Dialysis Center
Full name of responsible person
Street address
City
Yazd
2
Recruitment center
Name of recruitment center
Shahid Rahnemoon Dialysis Center
Full name of responsible person
Street address
City
Yazd
3
Recruitment center
Name of recruitment center
Taamin Ejtemaee Dialysis Center
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Sciences,yazd
Full name of responsible person
Dr. Hassan Mozaffari Khosravi
Street address
daneshjoo boulvard , shahid sadooghi of medical science,yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?