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.

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.

Study Overview

• Status: Terminated
• Conditions: Malnutrition; ESRD
• Intervention / Treatment: Dietary supplement: Nutritional Supplement ProStat 64 twice a day; Dietary supplement: Placebo supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Kansas Nephrology Physicians, PA
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • Western New England Renal Transplant Associates
  • Mississippi
    • Columbus, Mississippi, United States, 39705
      • Nephrology Associates
  • Missouri
    • St. Louis, Missouri, United States, 63136
      • Metro Hypertension & Kidney Center, LLC.
    • St. Peters, Missouri, United States, 63376
      • Midwest Nephrology Associates
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Center for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; 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
Placebo Comparator: B; 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; Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fresenius Medical Care North America
• Collaborators: Medical Nutrition USA, Inc.
• Investigators: Principal Investigator: Mark Kaplan, M.D., Fresenius Medical Care North America; Principal Investigator: Alp Ikizler, M.D., Vanderbilt University

Publications and helpful links

General Publications

• Ikizler TA, Wingard RL, Harvell J, Shyr Y, Hakim RM. Association of morbidity with markers of nutrition and inflammation in chronic hemodialysis patients: a prospective study. Kidney Int. 1999 May;55(5):1945-51. doi: 10.1046/j.1523-1755.1999.00410.x.
• Ikizler TA, Hakim RM. Nutrition in end-stage renal disease. Kidney Int. 1996 Aug;50(2):343-57. doi: 10.1038/ki.1996.323.
• Caglar K, Fedje L, Dimmitt R, Hakim RM, Shyr Y, Ikizler TA. Therapeutic effects of oral nutritional supplementation during hemodialysis. Kidney Int. 2002 Sep;62(3):1054-9. doi: 10.1046/j.1523-1755.2002.00530.x.
• Pupim LB, Flakoll PJ, Brouillette JR, Levenhagen DK, Hakim RM, Ikizler TA. Intradialytic parenteral nutrition improves protein and energy homeostasis in chronic hemodialysis patients. J Clin Invest. 2002 Aug;110(4):483-92. doi: 10.1172/JCI15449.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: February 12, 2007
• First Submitted That Met QC Criteria: February 12, 2007
• First Posted (Estimate): February 14, 2007

Study Record Updates

• Last Update Posted (Estimate): February 21, 2008
• Last Update Submitted That Met QC Criteria: February 12, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: ESRD; Hemodialysis; Malnutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 2006002; 061201 Vanderbilt IRB