Evaluation of the effect of oral L-Carnitine on liver enzymes in children diagnosed with ALL in the maintenance phase of therapy: A randomized clinical trial
Investigating the effect of adding oral L-carnitine to the treatment regimen of children with acute lymphoblastic leukemia in the maintenance phase on the level of liver enzymes.
Design
A double-blind randomized clinical trial study using block randomization and stratified by age on 98 patients. Randomization will be done using the software of www.sealedenvelope.com website.
Settings and conduct
The study will be conducted in the hematology and oncology ward of Ali Asghar Hospital in Tehran. The patients in the intervention and placebo groups will undergo the intervention for 2 months, and both groups will be examined every two weeks in terms of the mentioned liver enzymes until the end of the third month from the start of the intervention. Patients, clinical care providers and outcome assessors will be blinded in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children between 5 and 18 years old with acute lymphoblastic leukemia (ALL) undergoing chemotherapy in the maintenance phase, increased liver function test between grades 1-3, whose parents are satisfied with their child's participation in the study.
Exclusion criteria: suffering from opportunistic viral and bacterial infections, suffering liver and kidney dysfunction, and other underlying diseases.
Intervention groups
L-carnitine receiving group, placebo receiving group
Main outcome variables
Serum level of liver enzymes including Alanine transaminase (ALT), Aspartate transferase (AST), Alkaline phosphatase, Bilirubin, and blood platelet count.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201107049296N2
Registration date:2023-08-19, 1402/05/28
Registration timing:prospective
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Aziz Eghbali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2268 8027
Email address
eghbali.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral L-Carnitine on liver enzymes in children diagnosed with ALL in the maintenance phase of therapy: A randomized clinical trial
Public title
Evaluation of the effect of oral L-Carnitine on liver enzymes in children diagnosed with ALL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with acute lymphoblastic leukemia (ALL)
Age between 5 and 18 years
In maintenance phase of chemotherapy (under treatment with methotrexate and 6-mercaptopurine)
The serum level of liver enzymes between two and a half to ten times normal
Total bilirubin between 1.5 and 3 mg/dL
Gamma glutamyl transferase (GGT) serum level greater than or equal to 60
Parental informed consent to participate in the trial
Exclusion criteria:
Having viral hepatitis, including A, B and C
Active infection with any of the Epstein-Barr viruses, Cytomegalovirus, herpes simplex
Active bacterial infection
Any type of underlying liver dysfunction
Renal dysfunction is defined by a creatinine number higher than 2 times the upper normal level
Taking aspirin
Contracting AIDS
Current Hypothyroidism
History of epilepsy
Sickle cell anemia
Suffering from malabsorption disorders
Age
From 5 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the stratified block randomization method will be used using blocks with a size of 4 and stratified according to age. We will use the site https://www.sealedenvelope.com to provide random sequences. For the sequence concealment, it will be given to an independent individual and will be revealed case by case to the project researcher in coded form with A and B labels.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done using a placebo syrup identical in form to the original drug. Allocation between the groups is done based on the coded labels A and B on the glass of syrups, and only the independent person responsible for coding is aware of the type of labels.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran university of medical science., Next to Milad Tower., Hemmat Highway., Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.IUMS.FMD.REC.1401.570
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukaemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia
Primary outcomes
1
Description
Serum level of alanine transaminase (ALT)
Timepoint
4, 6, 8, 10 and 12 weeks after the intervention
Method of measurement
Serum spectrophotometry
Secondary outcomes
1
Description
Aspartate transferase (AST) serum level
Timepoint
4, 6, 8, 10 and 12 weeks after the intervention
Method of measurement
Serum Spectrophotometry
2
Description
Blood serum bilirubin level
Timepoint
4, 6, 8, 10 and 12 weeks after the intervention
Method of measurement
Serum spectrophotometry
3
Description
Serum alkaline phosphatase level
Timepoint
4, 6, 8, 10 and 12 weeks after the intervention
Method of measurement
Serum spectrophotometry
4
Description
Blood platelet count
Timepoint
4, 6, 8, 10 and 12 weeks after the intervention
Method of measurement
Cell counter
Intervention groups
1
Description
Intervention group: L-carnitine syrup (َAlborz pharmaceutical company, Iran) with a dose of 50 mg/Kg will be given in three times a day every 8 hours for a period of two months. The chemotherapy protocol will be weekly methotrexate at a dose of 20 mg/m2 (body surface) and 6 mercaptopurine daily at a dose of mg/m2 (body surface).
Category
Treatment - Drugs
2
Description
Control group: A placebo of the same shape and color in the same package as the intervention drugs (َAlborz pharmaceutical company, Iran) will be used in three divided doses every 8 hours for a period of two months. The chemotherapy protocol will be weekly methotrexate at a dose of 20 mg/m2 (body surface) and 6 mercaptopurine daily at a dose of mg/m2 (body surface).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tَehran Ali Asghar Children's Hospital
Full name of responsible person
Aziz Eghbali
Street address
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6413
Email
eghbali.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, next to the Milad Tower, Hemat Hwy
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
rezafalak@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?