Evaluation of the effect of oral L-Carnitine on liver enzymes in children diagnosed with A

Phase 2

Recruiting

• Conditions: Acute lymphoblastic leukaemia.; Acute lymphoblastic leukaemia; C91.0

• Registration Number: IRCT20201107049296N2
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum level of alanine transaminase (ALT). Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Serum spectrophotometry.

Secondary Outcome Measures

Name	Time	Method
Aspartate transferase (AST) serum level. Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Serum Spectrophotometry.;Blood serum bilirubin level. Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Serum spectrophotometry.;Serum alkaline phosphatase level. Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Serum spectrophotometry.;Blood platelet count. Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Cell counter.