Comparison the effectiveness and non effectiveness of L-carnitine in improvement of liver enzymes in patients treated with methotrexate and 6-mercaptopurine
This study will be done with aim to investigate the effectiveness of L-Carnitine in the improvement of liver enzymes in patients treated with methotrexate and 6-mercaptopurine. This study is a single blind clinical trial. The study population consisted of children with acute lymphoblastic leukemia treated with methotrexate and 6-mercaptopurine that are referred to the Mohammad Kermanshahi hospital of Kermanshah City. 36 persons will selected in available method and randomly will be divided into two groups of( 16 persons) tests and controls. Folic acid supplements are given to patients in both groups. In the intervention group 50 mg of L-Carnitine tablets or syrup per kg body weight up to2 grams is prescribed daily for 3 months under the supervision of pediatric specialists. The control group will receive placebo daily 50 mg per kg of body weight up to 2 grams for 3 months. Then in both groups of patients liver enzymes will be examined by blood tests in baseline of study and once every two weeks for 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604297677N5
Registration date:2016-05-10, 1395/02/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-10, 1395/02/21
Registrant information
Name
Mohamadreza Golpayegani
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6331
Email address
golpayegani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2016-08-15, 1395/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness and non effectiveness of L-carnitine in improvement of liver enzymes in patients treated with methotrexate and 6-mercaptopurine
Public title
Effectiveness of L-Carnitine in improvement of liver enzyme in patients treated with Methotrexate and 6-Mercaptopurine.
Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age less than 18 years; Patient informed consent .
Exclusion criteria: Patients with hypothyroidism –seizures; L-carnitine intolerance.
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-04-27, 1395/02/08
Ethics committee reference number
kums.rec.1395.58
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia [ALL]
Primary outcomes
1
Description
Aspartat Aminotransferase (AST)
Timepoint
Once every two weeks for 3 months
Method of measurement
Based on blood test
2
Description
Alanin Aminotransferase (ALT)
Timepoint
Once every two weeks for 3 months
Method of measurement
By blood test
Secondary outcomes
empty
Intervention groups
1
Description
Folic acid supplements are given to patients in both groups. In the intervention group 50 mg of L-Carnitine tablets or syrup per kg body weight up to2 grams is prescribed daily for 3 months under the supervision of pediatric specialists.
Category
Treatment - Drugs
2
Description
The control group will received placebo daily 50 mg per kg of body weight up to 2 grams for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Mohammad Kermanshahi Hospital
Full name of responsible person
Dr. Elaham Pourazar
Street address
Helala Ahmar Crossroads
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Elaham Pourazar
Position
Resident of Pediatric
Other areas of specialty/work
Street address
Dr Mohammad Kermanshahi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
pourazar.emd81@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Golpayegani
Position
Oncologists and Hematologists
Other areas of specialty/work
Street address
Dr Mohammad Kermanshahi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
mrgolpayegani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Elaham Pourazar
Position
Resident of Pediatric
Other areas of specialty/work
Street address
Dr Mohammad Kermanshahi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
pourazar.emd81@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)