In 2009, there were approximately 25,000 patients with Iran (3), this number increased to about 8% annually (4). In approximately 52.7% of the patients were treated with hemodialysis (5) the annual increase of 15% (6). Despite adequate hemodialysis for renal disease and adequate protein intake, long-term dialysis patients who are malnourished are. Protein malnutrition - energy is common in hemodialysis patients (7, 8). Studies performed in various states of protein malnutrition - Energy in hemodialysis patients from 16% to 90% have been reported (10-7).through the reduction of acyl-CoA reduces cardiac arrhythmias and ischemia, which is caused by reduced apoptosis. Deficiency of carnitine in patients with ESRD who have long dialysis are the most commonly happens while carnitine in the body from lysine and methionine synthesis is to achieve a balance of daily substance the body needs carnitine Exogenous the meat and dairy sources of carnitine exogenous precursors are (34), but patients on hemodialysis limited amounts of foods containing carnitine and the material it receives as cofactors and precursors of carnitine (such as B6 and niacin and vitamin C and lysine and methionineIt is not, therefore, important to justify a clinical trial designed to study the effect of carnitine supplementation on visceral protein levels in patients undergoing hemodialysis is designed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042913160N1
Registration date:2013-07-16, 1392/04/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-16, 1392/04/25
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
Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-08-05, 1392/05/14
Expected recruitment end date
2014-01-04, 1392/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of carnitine supplementation on visceral proteins in hemodialysis patients
Public title
Effect of l-carnitine on malnutrition in hemodialysis patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: patients on hemodialysis in last year, above 21 years old and did not use the drug for 8 weeks. Did not participate in other research projects.
Exclusion criteria: if a patient is suffering from an infectious disease or fever in last month or is taking antibiotics are excluded
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
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
Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Street address
yazd-sadoughi street
City
yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2013-04-29, 1392/02/09
Ethics committee reference number
20229
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis
2
Description of health condition studied
Malnutrition
ICD-10 code
E40-46
ICD-10 code description
Malnutrition
Primary outcomes
1
Description
pre albumin
Timepoint
First, after 3 months at the end of the study
Method of measurement
blood samples,mg/dl
2
Description
transferin
Timepoint
First, after 3 months at the end of the study
Method of measurement
blood samples,mg/dl
3
Description
total lymphocite count
Timepoint
First, after 3 months at the end of the study
Method of measurement
blood samples,mg/dl
4
Description
pre albumin
Timepoint
First, after 3 months at the end of the study
Method of measurement
blood samples,mg/dl
5
Description
c-reactive protein
Timepoint
First, after 3 months at the end of the study
Method of measurement
blood samples,mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
treatment group, received 1 carnitin oral vial of 1000 mg .
Category
Treatment - Drugs
2
Description
The control group did not receive carnitine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shhid Dr. Rahnamoon hospital
Full name of responsible person
Shima Dehghan
Street address
Yazd. Farrokhi str.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Science
Full name of responsible person
Hasan Mozaffari
Street address
Daneshjoo Boulevard
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi University of Medical Science
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
Yazd Shahid Sadoughi University of Medical Science
Full name of responsible person
Shima Dehghan
Position
Master sience student
Other areas of specialty/work
Street address
daneshjoo Boulevard
City
Yazd
Postal code
00988916978477
Phone
+98 35 1624 0691
Fax
Email
shimadehghan_84@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Science
Full name of responsible person
Shima Dehghan
Position
Master sience student
Other areas of specialty/work
Street address
Daneshjoo Boulevard
City
Yazd
Postal code
00988916978477
Phone
+98 35 1624 0691
Fax
Email
shimadehghan_84@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)