Clinical trial · Interventional
Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia
NCT02373579CI-TRIAL-00016950completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
| Omega-3 Fatty Acids | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention arm with Omega 3 FA
- description
- 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 .
- interventionNames
- Drug: Omega-3 Fatty Acids
- Drug: Methotrexate
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- 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 .
- interventionNames
- Drug: Methotrexate
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Child age: less than 17 years old. * Taking oral methotrexate in maintenance therapy. * Patients are at cycle one day zero. Exclusion Criteria: * Child infected by hepatitis B or C viruses. * Child taking medications or having a condition causing elevation in liver enzymes level other than methotrexate.(eg:thrombosis ,antibiotic therapy, infiltrating malignancy ,auto immune manifestations or having TPN) * Child remission. * Child death * Child drop out due to non compliance
References
Publications (1)
- DERIVEDElbarbary NS, Ismail EA, Farahat RK, El-Hamamsy M. omega-3 fatty acids as an adjuvant therapy ameliorates methotrexate-induced hepatotoxicity in children and adolescents with acute lymphoblastic leukemia: A randomized placebo-controlled study. Nutrition. 2016 Jan;32(1):41-7. doi: 10.1016/j.nut.2015.06.010. Epub 2015 Jul 17. PMID 26421385