ESRD, Malnutrition
Conditions
Keywords
Malnutrition, ESRD, Hemodialysis
Brief summary
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.
Detailed description
Fifty patients identified as having poor nutrition by the following criteria: 1. 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. 2. one of the four following criteria: 1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months 2. 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 3. Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month 4. Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion: 1. Serum transferrin concentration less than 225 mg/dl 2. 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. Patients will take the supplement/placebo twice a day. Measurements will be repeated at month 3. At the end of these measurements, all patients will be switched to open label ProStat64 for an additional 3 months. At month 6 all study procedures/labs are repeated and the study is complete.
Interventions
DIETARY_SUPPLEMENTNutritional Supplement ProStat 64 twice a day
DIETARY_SUPPLEMENTPlacebo supplement
Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months
Sponsors
Medical Nutrition USA, Inc.
Fresenius Medical Care North America
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months 2. 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 3. Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month 4. Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion: 1. Serum transferrin concentration less than 225 mg/dl 2. 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in visceral protein stores as measured by serum albumin | 3 months minimum; 6 months max |
Countries
United States
Outcome results
None listed