Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability by measuring superoxide dismutase (SOD) level changes.
研究概览
简要总结
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.
详细描述
The patients were divided into two groups :Group I: 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 .
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child age: less than 17 years old.
- •Taking oral methotrexate in maintenance therapy.
- •Patients are at cycle one day zero.
排除标准
- •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
研究组 & 干预措施
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 .
干预措施: Omega-3 Fatty Acids (Drug)
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 .
干预措施: Methotrexate (Drug)
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 .
干预措施: Methotrexate (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability by measuring superoxide dismutase (SOD) level changes.
时间窗: six months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability by measuring uric acids levels changes .
时间窗: Six months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability by measuring Malondialdehyde (MDA) level changes .
时间窗: six months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability by measuring Total antioxidant capacity (TAC) level changes.
时间窗: six months
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability by measuring ALT value changes.(six months)
研究者
Nancy Samir Elbarbary
Assistant professor
Ain Shams University