Protocol summary
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Study aim
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Comparison of the effect of erythropoietin and placebo with the combination of l-carnitine and erythropoietin on anemia in hemodialysis patients
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Design
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Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 24 patients on hemodialysis
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Settings and conduct
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This study will be conducted with the aim of comparison of the effect of erythropoietin and placebo with the combination of l-carnitine and erythropoietin on anemia in 24 hemodialysis patients attending Ali Ebne Abitaleb hospital in Zahedan city. After inclusion in the study, the patients will be assigned into two groups; erythropoietin and placebo 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 and in the erythropoietin and placebo group, in addition to erythropietin, the patients will receive l-carnitine placebo 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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group 1: receiving erythropietin 2000 IU three times a week subcutaneously plus l-carnitine placebo daily orally for three months
Intervention group 2: receiving erythropietin 2000 IU three times a week subcutaneously plus l-carnitine tablet 20 mg/kg daily orally
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Main outcome variables
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Serum hemoglobin level
General information
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Reason for update
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Editing the title of the clinical trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200225046620N1
Registration date:
2020-03-24, 1399/01/05
Registration timing:
registered_while_recruiting
Last update:
2020-12-10, 1399/09/20
Update count:
1
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Registration date
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2020-03-24, 1399/01/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-20, 1398/12/01
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Expected recruitment end date
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2020-12-21, 1399/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of erythropoietin and placebo with the combination of l-carnitine and erythropoietin on anemia in hemodialysis patients
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Public title
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The effect of l-carnitine and erythropoietin on anemia in hemodialysis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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To 30 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization with blocks of 6.
The patients will be randomly assigned into 2 groups of 12. Considering the sample size of 24 (12 patients in erythropoietin with group and 12 patients in erythropoietin plus l-carnitine group) , 4 blocks with 6 people will be selected; in each block there will be 3 cards of each group. So by selecting each block, 3 people will be assigned into each group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The person evaluating the patients won't be aware of the patients assignment
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-23, 1398/12/04
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Ethics committee reference number
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IR.ZAUMS.REC.1398.421
Health conditions studied
1
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Description of health condition studied
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Anemia
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ICD-10 code
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D63.1
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ICD-10 code description
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Anemia in chronic kidney disease
Primary outcomes
1
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Description
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Serum hemoglobin level
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Timepoint
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Before study, three month after taking drugs
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Method of measurement
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By measuring complete blood count in laboratory
Intervention groups
1
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Description
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Intervention group 1: receiving erythropietin 2000 IU three times a week subcutaneously for three months plus l-carnitine placebo daily orally for three months
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: receiving erythropietin 2000 IU three times a week subcutaneously plus l-carnitine tablet 20 mg/kg daily orally for three months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zahedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable