Effect of Omega 3 Supplementation on Nutritional Status and Oxidative Stress in Children and Adolescents With End Stage Renal Disease on Regular Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- improvement of nutritional status assessed by anthropometric measurements.
研究概览
简要总结
evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis
详细描述
Chronic Kidney Disease (CKD) is a medically challenging and economically demanding health issue that adds to child morbidity and mortality.
The prevalence of pediatric CKD has been reported to be ranging from 15 to 74.7 cases per million children.
With an earlier age of onset of CKD, there is a greater risk of comorbidities associated with the disease including: malnutrition, growth.
retardation, joint pain, dental problems, hypertension, dyslipidemia and cardiovascular disease.
Kidney wasting disease is a common and serious complication of CKD, affects approximately one-third of end stage renal disease (ESRD) patients on hemodialysis. Contributing factors to this malnutrition include poor appetite, various co-morbidities, dietary restrictions, inflammation, infection, metabolic acidosis and oxidative stress. Oxidative stress (OS), defined as disturbances in the pro-
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD children and adolescents on regular hemodialysis for at least 3 months
- •Age ranging from 6 to18 years.
排除标准
- •Systematic disease other than CKD eg SLE
- •Severe active infection.
- •Allergies to any of the ingredients in omega-3 product used in this study (e.g. fish oil, bovine gelatin).
- •Omega-3 fatty acid or any other antioxidants consumption within the last 6 months.
结局指标
主要结局
improvement of nutritional status assessed by anthropometric measurements.
时间窗: 6 months
including weight measure in kilograms ,height in meters, BMI calculated by division of weight on (height in meters)2
s. ionized calcium level
时间窗: 6 months
25(oh)vitamin D level
时间窗: 6 months
improvement of nutritional status assessed by laboratory investigations.
parathormone hormone level
时间窗: 6 months
increase antioxidant activity
时间窗: 6 months
measured by assessment of serum level of Human Glutathione peroxidase (GSH-Px)
mid upper arm circumference in centimeters
时间窗: 6 months
improvement of nutritional status assessed by anthropometric measurements.
triceps skin fold thickness in millimeter's
时间窗: 6 months
improvement of nutritional status assessed by anthropometric measurements.
improvement of nutritional status assessed by laboratory investigations.
时间窗: 6 months
serum albumin level
s.phosphorus level
时间窗: 6 months
decrease oxidative stress
时间窗: 6 months
measured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS)
alkaline phosphatase level
时间窗: 6 months
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
时间窗: 6 months
including fat mass index ( FMI)
次要结局
未报告次要终点
研究者
NohaSayed Ahmed Hamed Esmaeil
assistant lecturer
Tanta University