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ProStat Supplementation in Dialysis Patients
This study has been terminated.
( Increased use of commercial product; less eligible patients & poor enrollment. )
First Received: February 12, 2007   Last Updated: February 12, 2008   History of Changes
Sponsor: Fresenius Medical Care North America
Collaborator: Medical Nutrition USA, Inc.
Information provided by: Fresenius Medical Care North America
ClinicalTrials.gov Identifier: NCT00435123
  Purpose

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.


Condition Intervention
Malnutrition
ESRD
Dietary Supplement: Nutritional Supplement ProStat 64 twice a day
Dietary Supplement: Placebo supplement

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care North America:

Primary Outcome Measures:
  • Increase in visceral protein stores as measured by serum albumin [ Time Frame: 3 months minimum; 6 months max ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
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
B: Placebo Comparator
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435123

Locations
United States, Kansas
Kansas Nephrology Physicians, PA
Wichita, Kansas, United States, 67214
United States, Massachusetts
Western New England Renal Transplant Associates
Springfield, Massachusetts, United States, 01107
United States, Mississippi
Nephrology Associates
Columbus, Mississippi, United States, 39705
United States, Missouri
Metro Hypertension & Kidney Center, LLC.
St. Louis, Missouri, United States, 63136
Midwest Nephrology Associates
St. Peters, Missouri, United States, 63376
United States, Pennsylvania
Lankenau Center for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Fresenius Medical Care North America
Medical Nutrition USA, Inc.
Investigators
Principal Investigator: Mark Kaplan, M.D. Fresenius Medical Care North America
Principal Investigator: Alp Ikizler, M.D. Vanderbilt University
  More Information

Publications:
Responsible Party: Fresenius Medical Care North America ( Mark Kaplan, M.D., Vice-President Research )
Study ID Numbers: 2006002, 061201 Vanderbilt IRB
Study First Received: February 12, 2007
Last Updated: February 12, 2008
ClinicalTrials.gov Identifier: NCT00435123     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Fresenius Medical Care North America:
Malnutrition
ESRD
Hemodialysis

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 25, 2009