Clinical Efficacy, Feasibility, and Cost-effectiveness of Homemade Oral Nutrition Supplements on Patients on Hemodialysis With Protein-energy Wasting: a Parallel, Open-labeled, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month
研究概览
简要总结
The goal of this clinical trial is to learn if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis. It will also learn about the cost-effectiveness of homemade oral nutrition supplements. The main questions it aims to answer are:
- Does homemade oral nutrition supplements improve the nutritional status of patients on hemodialysis with protein energy wasting?
- What is the cost-effectiveness of homemade oral nutrition supplements?
Researchers will compare homemade oral nutrition supplements to commercial oral nutrition supplements to see if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis.
Participants will:
- Take homemade or commercial oral nutrition supplements every day for 6 months
- Have assessment of nutritional status performed by researchers every three monthly
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
- •on maintenance HD dialysis treatment (thrice weekly and 4-hour per session) for at least three months
- •age 18 - 70 year old
- •diagnosed with protein energy wasting using the malnutrition inflammation score (≥ 5)
排除标准
- •a history of poor adherence to HD treatment (frequently miss the HD treatment for more than one session every month)
- •a history of frequent hospitalization (more than once in the past one month)
- •on regular oral nutrition supplements
- •diagnosed with malignancy
- •pregnant or lactating women
- •allergic to study products such as soy milk or milk
结局指标
主要结局
Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month
时间窗: Baseline, 3-month, and 6-month
The Malnutrition Inflammation Score is a composite score used to determine protein energy wasting. It consists of 10 questions, each rated on a scale from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating more severe malnutrition and inflammation. A score of 5 or above suggests the presence of protein-energy wasting.
次要结局
- Changes from baseline in serum albumin at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in skeletal muscle mass at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in body fat mass at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in handgrip strength at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Acceptability of oral nutrition supplements(6-month)
- Changes from baseline in energy intake at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in intradialytic weight change at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in protein intake at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in serum potassium at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Cost-Effectiveness Ratio(6-month)
- Changes from baseline in serum phosphorus at 3-month and 6-month(Baseline, 3-month, and 6-month)
研究者
Khor Ban Hock
Senior Lecturer
Universiti Malaysia Sabah