跳至主要内容
临床试验/NCT04789031
NCT04789031已完成不适用

Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting

Taylor's University0 个研究点目标入组 54 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
主要终点
Changes in muscle status

研究概览

简要总结

This multi-centred randomized, open label-controlled trial consists of hemodialysis (HD) patients identified with protein energy wasting (PEW) using the International Society of Renal Nutrition and Metabolism criteria. Intervention provided was oral nutritional supplementation (ONS) for 6 months and changes in muscle status in response toward the treatment was measured using ultrasound imaging method pre- and post-intervention.

详细描述

This study is a multi-centred randomized, open label-controlled trial where a total of 54 HD patients (29 intervention; 27 control) with PEW were recruited from government, private and non-governmental organization settings. Patients were randomized to either the intervention or control group. The intervention group received ONS (475 kcal and 21.7 g of protein), daily for 6 months. Both intervention and control group received standard nutritional counseling during the study period.

Patients who consented were subjected to a screening for identification of PEW and other eligibility criteria. Patients who fulfilled the inclusion criteria were randomized to either control or intervention group. During the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline, 3rd months and 6th months for changes in muscle status using ultrasound imaging and bio-impedance spectroscopy method, malnutrition inflammation complex syndrome using Malnutrition-Inflammation Score, and other measures indicative of nutritional status including anthropometry, biochemistry, dietary intake and quality of life assessment. These parameters were compared at baseline and 6 months for within and between group differences using general linear model test.

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

入选标准

  • HD patients receiving standard dialysis treatment (3 sessions per week, 4 hours per session) for >3 months
  • Aged between 18 to 70 years old
  • Diagnosed with PEW using the ISRNM criteria

排除标准

  • History of poor adherence to HD treatment
  • Prolonged hospitalization or surgery in the past 3 months prior to recruitment
  • Diagnosed with inflammatory diseases or malignancy
  • Vegetarian
  • Regular intake of ONS

结局指标

主要结局

Changes in muscle status

时间窗: Baseline versus 6 months

Effect of ONS on improving muscle status using ultrasound imaging (quadriceps muscle thickness and cross-sectional area of the rectus femoris muscle) and bio-impedance spectroscopy method (measuring lean tissue mass)

次要结局

  • Changes in nutrition-related biochemistry measures(Baseline versus 6 months)
  • Changes in malnutrition-inflammation complex syndrome(Baseline versus 6 months)
  • Changes in quality of life(Baseline versus 6 months)
  • Changes in dietary parameters(Baseline versus 6 months)
  • Changes in anthropometric measures(Baseline versus 6 months)

研究者

发起方
Taylor's University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tilakavati Karupaiah

Prof Dr Tilakavati Karupaiah

Taylor's University

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