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Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia

NCT02373579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-02-27

No results posted yet for this study

Summary

Study the role of oxidative stress in methotrexate induced hepatic damage, and the possible protective effect of OMEGA-3 fatty acids against methotrexate hepatotoxicity using clinical and biochemical parameters.

Conditions

Interventions

DRUG

Omega-3 Fatty Acids

study group, included standard risk ALL pediatric patients who were supplemented with oral omega-3 capsule (one capsule / day) . Omega-3 was supplied as soft gelatin capsules in a dose of 1000 mg of omega-3 fatty acids/day .

DRUG

Methotrexate

control group, included pediatric patients with standard risk acute lymphoblastic leukemia in maintenance phase day 0 and receiving oral Methotrexate (20 mg / m2) weekly without any supplementation .

Sponsors & Collaborators

  • Nancy Samir Elbarbary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-10-31
Completion
2014-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02373579 on ClinicalTrials.gov