Randomized, Open Label, Controlled Clinical Trial of Egg Albumin-Based Protein Supplement Versus Renal Specific Oral Supplement in Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Malnutrition-Inflammation Score
研究概览
简要总结
Malnutrition is seen frequently in hemodialysis units in most developing countries. Malnutrition increases morbidity and mortality in this population and its treatment improves patient survival and health status The purpose of this study is to compare two strategies to improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml) versus egg albumin-based protein supplement (30 g) on a daily basis.
This trial uses the Malnutrition Inflammation Score (MIS) and Subjective Global Assessment (SGA) in addition to most used biochemical markers to determine nutritional status.
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
- •Chronic Kidney Disease in Hemodialysis
排除标准
- •Infection
- •Liver insufficiency
- •Cancer or neoplasia
- •Acquired immunodeficiency syndrome
- •Intestinal malabsorption syndrome
研究组 & 干预措施
Egg albumin-based protein supplement
Powder form, dosage 30 g daily, duration 6 months
干预措施: Egg albumin-based protein supplement (Dietary Supplement)
Renal-specific oral supplement
Liquid form, dosage 237 ml (one can) daily, duration 6 months
干预措施: Renal-specific oral supplement (Dietary Supplement)
结局指标
主要结局
Change in Malnutrition-Inflammation Score
时间窗: Bimonthly, up to six months
Change in Subjective Global Assessment
时间窗: Bimonthly, up to six months
次要结局
未报告次要终点
研究者
Rafael Gonzalez-Toledo
Affiliated Physician of the Nephrology Service
Centro Medico Lic Adolfo Lopez Mate