Protein Supplementation In Dialysis Patients
Exploring The Therapeutic Benefits Of Oral Protein Supplementation In Malnourished Dialysis Patients
研究概览
详细说明
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).
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with high inflammatory diseases, malignancy, cancer
- Vegetarian patients
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Ceprolac
Received supplementation which added 27.6g protein and 114kcal to daily nutritional intake as well as standard diet counselling for 6 months
|
The supplement was packed into two ~15g sachets in powder form of a 90-94% whey protein isolate and hydrolysed whey.
The protein powder was dissolved in 75-100ml water at room temperature and was ingested post meal once daily.
|
|
安慰剂比较:Dietary counseling (DC)
Received standard diet counselling only for 6 months.
|
Received standard dietary counseling at baseline and month 6.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum albumin
大体时间:Change from baseline serum albumin at 6 months of the study
|
Biochemistry marker that indicates nutritional status
|
Change from baseline serum albumin at 6 months of the study
|
|
Body mass index (BMI)
大体时间:Change from BMI at 6 months of the study
|
Index that depicts if one's current weight is ideal for their height
|
Change from BMI at 6 months of the study
|
合作者和调查者
调查人员
- 首席研究员:Tilakavati Karupaiah、Senior Lecturer
出版物和有用的链接
一般刊物
- Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
- Sahathevan S, Se CH, Ng S, Khor BH, Chinna K, Goh BL, Gafor HA, Bavanandan S, Ahmad G, Karupaiah T. Clinical efficacy and feasibility of whey protein isolates supplementation in malnourished peritoneal dialysis patients: A multicenter, parallel, open-label randomized controlled trial. Clin Nutr ESPEN. 2018 Jun;25:68-77. doi: 10.1016/j.clnesp.2018.04.002.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- FF-274-2012
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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