A Randomized, Placebo Controlled, Double Blind Study of the Use of a Nutritional Supplement, ProStat-64, in Chronic Hemodialysis Patients With Poor Nutritional Status.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 12
- 主要终点
- Increase in visceral protein stores as measured by serum albumin
研究概览
简要总结
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition. Subjects receive either ProStat 64 or Placebo for three months. At the end of this period, all subjects will receive ProStat-64 for a further 3 months at which time the study is ended. Parameters of nutritional status (lean body mass and serum protein) will be collected at baseline, 3 months and 6 months.
详细描述
Fifty patients identified as having poor nutrition by the following criteria:
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Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.
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one of the four following criteria:
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Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
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Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
-
Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
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Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:
-
Serum transferrin concentration less than 225 mg/dl
-
Serum prealbumin concentration less than 32 mg/dl
will be randomized to receive either ProStat 64 or placebo for 3 months. At Baseline a Dexa for lean body mass and labs for BUN, creatinine, glucose, serum albumin, prealbumin and C-reactive protein will be drawn. Cholesterol and transferrin will be recorded from the regular monthly labs if available. In addition, a protein catabolic rate will be calculated and a SGA will be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On hemodialysis
- •Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V >1.2)
- •Patient or next of kin able to sign consent form
- •Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.
- •Sub-optimal nutritional status identified by one of the four following criteria:
- •Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
- •Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
- •Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
- •Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:
- •Serum transferrin concentration less than 225 mg/dl
- •Serum prealbumin concentration less than 32 mg/dl
- •Patient is able to transfer with minimal or no assistance.
- •Not taking a caloric nutritional supplement for the last 30 days (e.g. Nepro, ProStat, Boost,etc).
排除标准
- •Active auto-immune, inflammatory or infectious disease
- •Documented malignancy within the last 12 months
- •Patients on unusual dietary restrictions
- •Life-expectancy less than 6 months
- •Inability to tolerate nutritional supplements
- •Patient does not exceed the DEXA machine weight limit.
结局指标
主要结局
Increase in visceral protein stores as measured by serum albumin
时间窗: 3 months minimum; 6 months max
次要结局
未报告次要终点