Objectives: Anemia is one of the complications in chronic renal failure. Patients treated with recombinant erythropoietin show resistance to erythropoietin treatment with increased risk of death. Haptoglobin is the main serum protein involved in hemoglobin metabolism with the anti-inflammatory property. Due to inhibitory effects of L-carnitine (LC) and conjugated linoleic acid (CLA) on inflammatory markers, lipid peroxidation and apoptosis, they can be used to treat anemia. The aim of current study is to investigate the effect of LC and CLA supplements on hemoglobin levels and inflammatory markers in male patients with chronic anemic kidney disease.
Design: After obtaining written informed consent, patients will be selected by a physician, and then demographic and anthropometric factors will be gathered for 40 patients.
Setting and Conduct: At the beginning of study, 7 ml of blood sample will be taken to measure the haptoglobin levels, IL-6, hs-CRP, iron, ferritin, TIBC, hemoglobin and hematocrit.
Intervention: 1000 mg LC and 2400 mg CLA supplements will be given daily for a month. Blood samples will be taken at the end of study to measure above mentioned factors.
Participants including major eligibility criteria: Anemic male patients with chronic kidney disease and ages above 20 years. Women and patients with diabetes; cardiovascular and lung disease will be excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503055144N7
Registration date:2017-05-18, 1396/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-18, 1396/02/28
Registrant information
Name
Ali Nemati
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0052
Email address
a.nemati@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-Carnitine (LC) and conjugated linoleic acid (CLA) supplements on hemoglobin levels in CKD patients with different haptoglubin genotype
Public title
Effect of L-Carnitine (LC) and conjugated linoleic acid (CLA) supplements on hemoglobin levels in CKD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients with anemic chronic kidney disease over 20 years old
Exclusion criteria:
Women; Male patients with other disease such as cardiovascular; lung disease; diabetes
Age
From 20 years old to 80 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
کمیته اخلاق دانشگاه علوم پزشکی اردبیل
Secondary trial Id
Arums.REC.93.95
Registration date
2015-08-20, 1394/05/29
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Ardabil University of Medical Sciences
Street address
Ethic Committee of Ardabil University of Medical Sciences, Vice Chancellor for Research, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5318985991
Approval date
2015-08-20, 1394/05/29
Ethics committee reference number
Arums.REC.93.95
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N17- N19
ICD-10 code description
N18.2-N18.4
Primary outcomes
1
Description
Anemia
Timepoint
At the end of study
Method of measurement
Measurement of hemoglobin and hematocrit
Secondary outcomes
1
Description
Height
Timepoint
At the beginning of intervention
Method of measurement
Stadiometers
2
Description
L-Carnitine
Timepoint
One month
Method of measurement
Milligram
3
Description
Conjugated linoleic acid
Timepoint
One month
Method of measurement
Milligram
4
Description
Weight
Timepoint
At the beginning and end of intervention
Method of measurement
Digital scales
5
Description
Hemoglobin
Timepoint
At the beginning and end of intervention
Method of measurement
Cell counter
6
Description
Hematocrit
Timepoint
At the beginning and end of intervention
Method of measurement
Cell counter
7
Description
Serum iron
Timepoint
At the beginning and end of intervention
Method of measurement
Photometric method
8
Description
Serum Ferritin
Timepoint
At the beginning and end of intervention
Method of measurement
Chemiluminescence immunoassay
9
Description
hsCRP
Timepoint
At the beginning and end of intervention
Method of measurement
Immunometric method
10
Description
Srum TIBC
Timepoint
At the beginning and end of intervention
Method of measurement
Photometric method
11
Description
Serum interleukin-6
Timepoint
At the beginning and the end of intervention
Method of measurement
ELISA
12
Description
DNA extraction
Timepoint
At the end of intervention
Method of measurement
Cinnagen kit
13
Description
Haptoglobin genotype
Timepoint
At the end of intervention
Method of measurement
PCR method
Intervention groups
1
Description
Given 1000 milligram L-carnitine and 2400 milligram CLA per day for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil University Of Medical Science
Full name of responsible person
Ali Nemati
Street address
Biochemistry Dept., Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Ardabil University of Medical Sciences
Full name of responsible person
Mohsen Sagha
Street address
Vice Chancellor for Research Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
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 Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Biochemistry Dept, Faculty of Medicine, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Postal code
5618953141
Phone
+98 45 3351 0052
Fax
+98 45 3351 2788
Email
ali.nemati@arums.ac.ir
Web page address
http://www.arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Biochemistry Dept., Faculty of Medicine, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Postal code
5618953141
Phone
+98 45 3351 0052
Fax
+98 45 3351 0057
Email
ali.nemati@arums.ac.ir
Web page address
http://www.arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Biochemistry Dept., Faculty of Medicine, University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5618953141
Phone
+98 45 3351 0052
Fax
+98 45 3351 0057
Email
ali.nemati@arums.ac.ir
Web page address
http://www.arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)