The aim of present study was to compare combination therapy with Atorvastatin and Carnitine versus Atorvastatin alone on lipid profile of hemodialized patients. In a single center clinical trial study, 50 hemodialized patients who referred to Imam-Reza Hospital of Tabriz University of Medical Sciences will select randomly and with using random numbers table will allocate in two groups of intervention and control group. Inclusion criteria are, hemodialized patients, age between 18 to 75 years old, and informed consent form for participating in study. Exclusion criteria is using any medication which effect on lipid profile of patients. In intervention group patients will receive 10 to 80 mg Atorvastatin daily (based on primary lipid profile level) with 1000 mg Carnitine three times in a day with daily meal. In control group patients receive only 10 to 80 mg Atorvastatin daily (based on primary lipid profile level). Patients will follow up for 6 months. Lipid profile level will measure at beginning of study, first month, third month, and also at the end of 6th month. Decrease in lipid profile level is as primary variable of study and side effect is as secondary variable of present study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604273742N3
Registration date:2016-05-14, 1395/02/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-14, 1395/02/25
Registrant information
Name
Hamid Noshad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 5023
Email address
noshadh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of combination therapy with Atorvastatin and Carnitine versus Atorvastatin alone on lipid profile of hemodialized patients
Public title
Comparison of combination therapy with Atorvastatin and Carnitine versus Atorvastatin alone on lipid profile of hemodialized patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemodialized patients; age between 18 to 75 years old; informed consent form for participating in study. Exclusion criteria: using any medication which effect on lipid profile of patients.
Age
From 18 years old to 75 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
Tabriz University of Medical Sciences.
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
TBZMED.REC.1394.767
Health conditions studied
1
Description of health condition studied
Hyperlipidaemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
Triglyceride
Timepoint
Beginning of study, first month, third month, 6th month.
Method of measurement
milligrams per deciliter
2
Description
high density lipoprotein (HDL)
Timepoint
Beginning of study, first month, third month, 6th month.
Method of measurement
milligrams per deciliter
3
Description
low density lipoprotein (LDL)
Timepoint
Beginning of study, first month, third month, 6th month.
Method of measurement
milligrams per deciliter
4
Description
total cholesterol
Timepoint
Beginning of study, first month, third month, 6th month.
Method of measurement
milligrams per deciliter
Secondary outcomes
1
Description
Adverse effects
Timepoint
First month, third month, 6th month.
Method of measurement
History and clinical examination
Intervention groups
1
Description
In intervention group: Patients will receive 10 to 80 mg Atrovastatine daily based on primary lipid profile with 1000 mg Carnitine three times in a day for six months.
Category
Treatment - Drugs
2
Description
In control group: Patients will receive 10 to 80 mg Atrovastatine daily based on primary lipid profile for six months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam-Reza Hospital
Full name of responsible person
Dr Hamid Noshad
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
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 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
Dr Davoud Mohammadi Nejad
Position
Assistant of Internal Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
noshadh@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Internal Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Full name of responsible person
Dr Hamid Noshad
Position
Subspecialty of Nephrology
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
noshadh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Davoud Mohammadi Nejad
Position
Assistant of Internal Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
reza.piri@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)