NCT00435123

ProStat Supplementation in Dialysis Patients

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Fresenius Medical Care North America · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malnutrition
• ESRD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional Supplement ProStat 64 twice a day
DIETARY_SUPPLEMENT	Placebo supplement	Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-02-14
• Last updated: 2008-02-21

Locations

6 sites across 1 country: United States