The Impact of Predialytic Oral Protein-based Supplements on Nutritional Status and Quality of Life in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- effect on quality of life
研究概览
简要总结
The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients
详细描述
Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD .
Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult hemodialysis patients (≥18 years of age).
- •Received dialysis for at least 6 months prior to study screening.
- •Receive hemodialysis at least 3 times per week .
排除标准
- •Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .
- •Participants with an allergy to any ingredients in the nutritional supplements.
- •Persistent hyperkalemia or hyperphosphatemia (defined as the last 3 months).
- •Significant edema and fluid overload.
- •Hepatic patients
结局指标
主要结局
effect on quality of life
时间窗: 3 months
assessment of quality of life change at 3 months from baseline using the kidney disease quality of life 36 (KDQOL-36) short form
effect on nutritional status
时间窗: 3 months
assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)
次要结局
- effect on BMI(3 months)
- effect on serum albumin(3 months)
- dialysis adequacy(3 months)
- mid arm circumference and triceps skin fold(3 months)
研究者
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Lecturer
Alexandria University