Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia
NCT ID: NCT02373579
Last Updated: 2015-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2012-06-30
2014-10-31
Brief Summary
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Detailed Description
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Group II: 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 . This is in addition to chemotherapy from day one of maintenance phase receiving oral Methotrexate (20 mg / m2) Weight -adjusted doses on days 8, 15, 22, 29,36,43,50,57,64,71and 78).
Both groups were followed up for six months . All patients were under free diet and were maintained on standard diet throughout the study ( 6 months). None of them were on regular vitamin supplementation before diagnosis or at time of chemotherapy administration.
Patients follow up:
The patients were followed up every three week for the whole study period for assessing the effect and compliance to both MTX and Omega-3 fatty acid and for monitoring any potential adverse effect.
Group I were asked on each visit about signs of hepatic toxicity ( fatigue , weakness , loss of appetite , vague abdominal pain , color of urine and sclera and jaundice ), their laboratory results were revised to know level of ALT as a marker of liver injury .
Group II were asked on each visit about signs of hepatotoxicity , their laboratory data were revised , any side effects resulted from use Omega-3 fatty acids:
(increased bleeding tendency, fishy smell , nausea , diarrhea , or if there is any relapses occurred , and to be sure that the patients were compliant to prescribed medication.
Investigations:
Blood samples were collected from every patient at day 0 of maintenance and after six months for estimation of Malondialdehyde (MDA), Total antioxidant capacity (TAC), super oxide dismutase ,liver function tests and uric acids . Blood was collected into heparinised tubes which were protected from light and processed immediately after sampling. At the time of collecting the blood samples, patients were free of any potentially confounding or interfering conditions, such as infections or fever.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention arm with Omega 3 FA
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 .
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 .
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 .
control group
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 .
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 .
Interventions
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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 .
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 .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Taking oral methotrexate in maintenance therapy.
* Patients are at cycle one day zero.
Exclusion Criteria
* 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
2 Years
16 Years
ALL
No
Sponsors
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Nancy Samir Elbarbary
OTHER
Responsible Party
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Nancy Samir Elbarbary
Assistant professor
References
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Elbarbary 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.
Other Identifiers
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Ain Shams University 1351
Identifier Type: -
Identifier Source: org_study_id