Status:
TERMINATED
ProStat Supplementation in Dialysis Patients
Lead Sponsor:
Fresenius Medical Care North America
Collaborating Sponsors:
Medical Nutrition USA, Inc.
Conditions:
Malnutrition
ESRD
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00435123
Start Date
July 1 2007
End Date
January 1 2008
Last Update
February 21 2008
Active Locations (6)
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1
Kansas Nephrology Physicians, PA
Wichita, Kansas, United States, 67214
2
Western New England Renal Transplant Associates
Springfield, Massachusetts, United States, 01107
3
Nephrology Associates
Columbus, Mississippi, United States, 39705
4
Midwest Nephrology Associates
City of Saint Peters, Missouri, United States, 63376