In this study hemodialysis children will be assessed in order to determine the effects of l-carnitine supplementation on serum concentrations of inflammatory factors,lipid profile and serum glucose.
Design
This study will be conducted as a randomized controlled trial. Subjects were randomly divided into two groups including 15 subjects (receiving l-carnitine supplement) and control (placebo). stratified blocked randomization method will be used to randomly assign patients to the two groups.
Settings and conduct
Subjects were randomly divided into two groups including 15 subjects intervention and control group.For each patient anthropometric measurements and general characteristics will be assessed at the baseline and end of the study will be filled. 24-h food record questionnaire in order to assess of food intake and pediatrics quality of life will be complete at the beginning and end of trial. 7 cc fasting blood samples from each patient will be taken at the beginning and end of the intervention. researcher and patient will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 6 -18 years old; at least 2 times a week dialysis; three months pass after dialysis at least; deficiency of carnitine; Exclusion criteria: pregnancy; use of lipid lowering and …drugs; autoimmune, infectious…disease and disorders;nutritional support;use of l-carnitine in past 3 month
Intervention groups
Intervention group will receive daily 50 mg per kg/bw l-carnitine supplement from Alborz daru company for 8 weeks.All the patients will be monitored for consumption of syrup. The control group will receive daily 50 mg per kg/bw of placebo from The Institute of Pharmaceutical Sciences of Tehran university of medical science for 8 weeks.All the patients will be monitored for consumption of syrup.
Main outcome variables
inflammatory markers;serum glucose;lipid profile;apo A
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170202032367N2
Registration date:2019-08-11, 1398/05/20
Registration timing:registered_while_recruiting
Last update:2019-08-11, 1398/05/20
Update count:0
Registration date
2019-08-11, 1398/05/20
Registrant information
Name
Hossien Imani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
h-imani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of l-carnitine supplementation on inflammatory markers, serum glucose and lipids in hemodialysis children
Public title
Effect of l-carnitine supplementation on inflammation, blood glucose and lipids in hemodialysis children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
at least 2 times a week dialysis
three months pass after dialysis at least
plasma carnitine to carnitine free ratio greater than 0.4 (indicating a lack of carnitine)
desiring to participate in this study
Exclusion criteria:
pregnanacy
use of non-steroidal and steroidal anti-inflammatory, lipid lowering and beta-blocker medications
autoimmune diseases, infectious, inflammatory disease, cardiovascular disease, thyroid disorders, thrombocytopenia
nutritional support (enteral and parenteral nutrition)
Age
From 6 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into two groups: the l-carnitine supplementation group and the placebo group. stratified blocked randomization method will be used to randomly assign patients to the two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, researcher and outcome assessor will be kept blind in this study
Placebo
Used
Assignment
Parallel
Other design features
The assessment of improvement in physical health, mental health, performance and quality of life, and reduction of complications are also among the goals.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran university of medical science
Street address
Keshavarz Beulvard, Naderi St, Hojjatdoust alley, No 44 , schools of nutritional sciences and dietetics
City
Tehran
Province
Tehran
Postal code
1416643931
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.TUMS.VCR.REC.1398.102
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, stage 5
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
2
Description of health condition studied
dialysis complications
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
3
Description of health condition studied
Dialysis-induced inflammation
ICD-10 code
T85.7
ICD-10 code description
Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts
4
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified
5
Description of health condition studied
hyperglycemia
ICD-10 code
R73.9
ICD-10 code description
Hyperglycemia, unspecified
6
Description of health condition studied
carnitine deficiency
ICD-10 code
E71.448
ICD-10 code description
Other secondary carnitine deficiency
7
Description of health condition studied
Disorder of fatty-acid metabolism
ICD-10 code
E71.30
ICD-10 code description
Disorder of fatty-acid metabolism, unspecified
Primary outcomes
1
Description
interleukin-6
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assay
2
Description
high sensitivity c-reactive protein
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Immunoturbidimetry
3
Description
total cholesterol
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic
4
Description
serum tryglycerides
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic
5
Description
low density lipoprotein cholesterol
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic
6
Description
high density lipoprotein cholesterol
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic
7
Description
serum glucose
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic
8
Description
apolipoprotein A
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic
9
Description
serum carnitine
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA assy
10
Description
Serum albumin
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic
Secondary outcomes
1
Description
quality of life
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
questionnare (PedsQL)
2
Description
nutritional status (calorie and nutrients intake)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Food record questionnaire
3
Description
Anthropometric index(weight, height,WHR and Body Mass Index)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Analogue scale for weight, height, WHR and CDC chart
4
Description
acyl carnitine
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
spectrometry
Intervention groups
1
Description
Intervention group: Intervention group will receive daily 50 mg per kg of body weight l-carnitine supplement for 8 weeks. L-carnitine syrups will be purchased from the Alborz daru Company. All the patients will be monitored for consumption of syrup by weekly checklists and recall messages
Category
Treatment - Drugs
2
Description
ControThe control group will receive daily 50 mg per kg of body weight of placebo for 8 weeks. placebo syrups will be purchased from the The Institute of Pharmaceutical Sciences of Tehran university of medical scienced . All the patients will be monitored for consumption of syrup by weekly checklists and recall messages.l group: