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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201107049296N2
Enrollment
98
Registered
2023-08-19
Start date
2023-09-06
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphoblastic leukaemia. Acute lymphoblastic leukaemia

Interventions

Intervention 1: 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 c

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAziz Eghbali

Iran University of Medical Sciences

eghbali.a@iums.ac.ir+98 21 2268 8027

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026