ProStat Supplementation in Dialysis Patients

Study Overview
=================
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: 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. 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 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.

Official Title
-----------------
A Randomized, Placebo Controlled, Double Blind Study of the Use of a Nutritional Supplement, ProStat-64, in Chronic Hemodialysis Patients With Poor Nutritional Status.

Conditions
-----------------
Malnutrition, ESRD

Intervention / Treatment
-----------------
* Dietary Supplement: Nutritional Supplement ProStat 64 twice a day
* Dietary Supplement: Placebo supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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). 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Patients are randomly assigned to receive either Active Comparator (ProStat 64) or placebo for the first 3 months. At the end of this, all patients receive open label ProStat64. | Dietary Supplement: Nutritional Supplement ProStat 64 twice a day<br> <br> |
| Placebo Comparator: B<br>Patients are randomly assigned to Placebo Comparator or Active Comparator (ProStat 64). At the end of 3 months, all patients receive active ProStat 64 | Dietary Supplement: Placebo supplement<br>* Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in visceral protein stores as measured by serum albumin |  | 3 months minimum; 6 months max | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition, ESRD, Hemodialysis