Exploring The Therapeutic Benefits Of Oral Protein Supplementation In Malnourished Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 主要终点
- Body mass index (BMI)
研究概览
简要总结
The dialysis population has a strikingly high incidence of mortality. The life expectancy of chronic dialysis patients is 20 years less than that of the general population. Approximately 50% of individuals with end stage renal disease (ESRD) die from a cardiovascular (CV) cause with mortality being 15 to 30 times higher than the age-adjusted CV mortality in the general population. There is also a steady increase of patients with diabetes and the older age groups coming into dialysis. The treatment of patients with ESRD aims at prolonging life, achieving good nutritional status and promoting the best possible functioning and quality of life (QOL). Several factors that are beyond adequacy of dialysis predict high mortality in ESRD patients. Associated co-morbidities and malnutrition factors are independently associated and the combined presence of both malnutrition and co-morbidities manifest the worst survival.Therefore this study investigates the efficacy of protein supplementation in improving health status and quality of life among peritoneal dialysis (PD) patients. This research will also generate basic data about significant health markers critical to the health status of PD patients.
详细描述
This study is a randomised, open labeled controlled trial where a total of 74 PD patients (37 supplemented; 37 control) were recruited from government and private settings. Subjects were randomised to either the intervention or control group. The intervention group received hydrolysed whey protein supplement and diet counselling for 6 months while the control group received only diet counselling for 6 months.
Patients who consented were first subjected to a screening for identification of eligible subjects. The screening involved basic anthropometry measures (height, weight, BMI), routine biochemistry result obtained from medical record, assessment of nutritional status and dietary evaluation. About 4ml of pre-dialysis blood was also collected by respective nurses for additional laboratory parameters (hsCRP).
During the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline and end of the study (at 6 months) for anthropometry assessment, laboratory results, medical condition, hospitalisations, nutritional status, dietary intake and compliance towards supplementation (intervention group only).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 18 years old and ≤70 years old
- •Undergone dialysis at least for 6 months.
- •Categorised as malnourished based on BMI <24 kg/m² and serum albumin ≤40 g/L criteria
- •No incidence of hospitalisation for past 3 months, free of infection/sepsis and have not undergone surgery for past 6 months.
排除标准
- •Patients with high inflammatory diseases, malignancy, cancer
- •Vegetarian patients
研究组 & 干预措施
Ceprolac
Received supplementation which added 27.6g protein and 114kcal to daily nutritional intake as well as standard diet counselling for 6 months
干预措施: Ceprolac (Dietary Supplement)
Dietary counseling (DC)
Received standard diet counselling only for 6 months.
干预措施: Dietary counseling (DC) (Other)
结局指标
主要结局
Body mass index (BMI)
时间窗: Change from BMI at 6 months of the study
Index that depicts if one's current weight is ideal for their height
Serum albumin
时间窗: Change from baseline serum albumin at 6 months of the study
Biochemistry marker that indicates nutritional status
次要结局
未报告次要终点
研究者
Tilakavati Karupaiah
Senior Lecturer
National University of Malaysia