Evaluation of the effect of intravenous Carnitine on hemoglobin and hematocrit level in chronic renal disease patients who are under hemodialysis treatment
The purpose of this study is to investigate the effect of intravenous Carnitine on anemia in chronic renal disease patients who are under hemodialysis treatment. A total of 29 patients who were under hemodialysis for at least one year and they hadn’t other reasons for their anemia were enrolled. The patients were assigned into two groups using a balanced block randomization method. After each dialysis session (3 times a week for 3 months), the intervention group was received an injection of 1 grams of intravenous Carnitine while the placebo group received 1 grams of distilled water as placebo. The levels of hemoglobin and hematocrit were measured and compared in each group before and after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010044865N1
Registration date:2010-11-18, 1389/08/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-18, 1389/08/27
Registrant information
Name
Maryam Khodaverdi
Name of organization / entity
Zanjan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 24 2526 5000
Email address
skhodaverdi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2004-06-17, 1383/03/28
Expected recruitment end date
2004-09-18, 1383/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intravenous Carnitine on hemoglobin and hematocrit level in chronic renal disease patients who are under hemodialysis treatment
Public title
Effect of intravenous Carnitine on anemia in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hb less than10mg/dl, patients who had dialysed at least for one year, ferritin more than or equal to 100, SI/TIBC more than 20%, normal LFT, PTH less than or equal to 150pg/ml, negative β-HCG in female patients
Exclusion criteria: receiving carnitine in 2 months prior to the study, pregnancy (positive β-HCG), Liver disease, ferritin less than 100, SI/TIBC less than 20%, PTH more than 150pg/ml
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
29
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Blvd., Zanjan
City
Zanjan
Postal code
4515613191
Approval date
2004-03-16, 1382/12/26
Ethics committee reference number
13821216
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic renal failure
2
Description of health condition studied
Anaemia
ICD-10 code
D63
ICD-10 code description
Anaemia in chronic diseases classified elsewhere
Primary outcomes
1
Description
Hb
Timepoint
Before and after the intervention
Method of measurement
cell counter
2
Description
Hct
Timepoint
Before and after the intervention
Method of measurement
cellcounter
Secondary outcomes
1
Description
ferritine
Timepoint
before intervention
Method of measurement
Selectra Autoanalyzer
2
Description
TIBC
Timepoint
befor intervention
Method of measurement
Autonalizer selectra
3
Description
Liver Function Test
Timepoint
before intervention
Method of measurement
Selectra Autoanalyzer
4
Description
Paratormon Hormone
Timepoint
before intervention
Method of measurement
Selectra Autoanalyzer
5
Description
Pregnancy test-BHCG
Timepoint
before intervention
Method of measurement
Statfax Eliza
6
Description
Serum iron
Timepoint
before intervention
Method of measurement
Selectra Autoanalyzer
Intervention groups
1
Description
Intervention: carnitine, 1 gr interavenous, 3 times a week (after each dialysis session) for 3 months (36 sessions)
Category
Treatment - Drugs
2
Description
Control: dirtillor water, 1 gr intravenous, (3 times a week (after each dialysis session), for 3 months (36 sessions)