Comparison of the effect of erythropoietin alone with the combination of l-carnitine and erythropoietin on anemia in hemodialysis patients
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 50 patients on hemodialysis
Settings and conduct
This study will be conducted with the aim of comparison of the effect of erythropoietin alone with the combination of l-carnitine and erythropoietin on anemia in 50 hemodialysis patients attending Ali Ebne Abitaleb hospital in Zahedan city. After inclusion in the study, the patients will be assigned into two groups; erythropoietin alnoe and erythropietin plus l-carnitine group. Erythropietin will be given with a dose of 2000 IU three times a week subcutaneously in both groups and in the erythropietin plus l-carnitine group, l-carnitine tablet will be given with a dose of 20 mg/kg daily orally. Patients in both groups will be followed up for 3 months and after the treatment, the hemoglobin level will be measured by laboratory in both groups and will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of less than 30 years, having a history of at least 6 month of dialysis
Exclusion criterion: having an active infectious or inflammatory disease
Intervention groups
Intervention group 1: receiving erythropietin 2000 IU three times a week subcutaneously
Intervention group 2: receiving erythropietin 2000 IU three times a week subcutaneously plus l-carnitine tablet 20 mg/kg daily orally
Main outcome variables
Serum hemoglobin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200225046620N1
Registration date:2020-03-24, 1399/01/05
Registration timing:registered_while_recruiting
Last update:2020-03-24, 1399/01/05
Update count:1
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
Vahid Sheikhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
dr.sheikhie@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of erythropoietin alone with the combination of l-carnitine and erythropoietin on anemia in hemodialysis patients
Public title
The effect of l-carnitine and erythropoietin on anemia in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of less than 30 years
Having a history of at least 6 month of dialysis
Exclusion criteria:
Having an active infectious or inflammatory disease
Age
To 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 10.
The patients will be randomly assigned into 2 groups of 25. Considering the sample size of 50 (25patients in erythropoietin group and 25 patients in erythropoietin plus l-carnitine group) , 5 blocks with 10 people will be selected; in each block there will be 5 cards of each group. So by selecting each block, 5 people will be assigned into each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the patients won't be aware of the patients assignment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.ZAUMS.REC.1398.421
Health conditions studied
1
Description of health condition studied
Anemia
ICD-10 code
D63.1
ICD-10 code description
Anemia in chronic kidney disease
Primary outcomes
1
Description
Serum hemoglobin level
Timepoint
Before study, three month after taking drugs
Method of measurement
By measuring complete blood count in laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: receiving erythropietin 2000 IU three times a week subcutaneously for three months
Category
Treatment - Drugs
2
Description
Intervention group 2: receiving erythropietin 2000 IU three times a week subcutaneously plus l-carnitine tablet 20 mg/kg daily orally for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Fatemeh Attaran Kakhk
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Attaran Kakhk
Position
Pediatrics resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Attaran Kakhk
Position
Pediatrics resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Attaran Kakhk
Position
Pediatrics resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available