NCT02581449Unknown2 期
Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 主要终点
- effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde
研究概览
简要总结
The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 8 and 18 years old
- •Patients treated with HD for at least 6 months
排除标准
- •Patients with malignancy and active inflammatory disease.
- •Patients who received vitamin E or any antioxidant treatment during the past 3 months.
研究组 & 干预措施
placebo group
Placebo Comparator
empty soft gelatin capsules with matched size, color and shape once daily for four months
干预措施: empty soft gelatin capsules (Other)
omega-3 group
Experimental
omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months
干预措施: omega-3 (Dietary Supplement)
结局指标
主要结局
effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde
时间窗: four months
次要结局
- effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)(four months)
研究者
Areej Mohamed Ateya
teaching assistant
Ain Shams University
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