The effect of B complex and L-carnitine on preventing increased liver enzyme levels

Determining the efficacy of B complex and L-carnitine on preventing increased levels of aminotransferases, triglycerides, and bilirubin in patients with acute lymphoblastic leukemia treated with pegasparginase

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250605066072N1

Enrollment

Registered

2025-07-11

Start date

2025-07-06

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Condition 1: Acute lymphoblastic leukemia. Condition 2: Aspartate aminotransferase enzyme level. Condition 3: Bilirubin level. Condition 4: Triglyceride levels. Condition 5: Alanine aminotransferase level. Acute lymphoblastic leukemia [ALL]

Interventions

Intervention 1: Control Group: The control group will receive treatment with the standard Peg-asparaginase protocol as follows: During the induction phase, patients will be administered Peg-asparagina

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Children under 18 years old Suffering from Acute lymphoblastic leukemia (ALL) Patients who are treated with the same treatment protocol with pegasparginase at a dose of 2500 Milligrams per square meter of body surface area and regularly refer to Shahid Sadoughi Clinic in Yazd to receive chemotherapy regimen according to the protocol.

Exclusion criteria

Exclusion criteria: Pre-existing severe liver disease (such as cirrhosis, hepatitis) Use of other hepatotoxic drugs Simultaneous use of other liver protective agents (antioxidant drugs, coenzymes, etc.) Use of B complex and L-carnitine in the past month

Design outcomes

Primary

Measure	Time frame
Aspartate aminotransferase enzyme level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Sample type: Minimum 0.1 ml venous blood sample, Measurement method: Photometric method, Normal range: 5 to 40.;Bilirubin level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Sample type: At least one milliliter of venous blood sample, Measurement method: Photometric method, Normal range for direct bilirubin: 0 to 0.2 and normal range for total bilirubin: 0.1 to 1.2.;Triglycerides level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Sample type: At least 0.6 ml of venous blood sample, Measurement method: Photometric method, Normal range: up to 150, Necessary preparation before sampling: 12-hour fasting.;Alanine aminotransferase enzyme level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Sample type: At least one milliliter of venous blood sample, Measurement method: Photometric method, Normal range: 5 to 40.	—

Measure

Time frame

Aspartate aminotransferase enzyme level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Sample type: Minimum 0.1 ml venous blood sample, Measurement method: Photometric method, Normal range: 5 to 40.;Bilirubin level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Sample type: At least one milliliter of venous blood sample, Measurement method: Photometric method, Normal range for direct bilirubin: 0 to 0.2 and normal range for total bilirubin: 0.1 to 1.2.;Triglycerides level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Sample type: At least 0.6 ml of venous blood sample, Measurement method: Photometric method, Normal range: up to 150, Necessary preparation before sampling: 12-hour fasting.;Alanine aminotransferase enzyme level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Sample type: At least one milliliter of venous blood sample, Measurement method: Photometric method, Normal range: 5 to 40.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNajmesadat Hashemi

Yazd University of Medical Sciences

najmehashemi73@gmail.com+98 35 3821 6955

Outcome results

None listed

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