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Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

This study has been terminated.
(funding exhausted)
Sponsor:
Collaborator:
Ross Laboratories
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179205
First received: September 13, 2005
Last updated: August 5, 2008
Last verified: August 2008
History of Changes
  Purpose

In this study, the investigators hypothesize that long-term administration of adequate intradialytic oral nutritional supplementation will increase visceral protein concentrations and somatic protein stores in malnourished chronic hemodialysis patients.


Condition Intervention Phase
End Stage Renal Disease
 Drug: Nepro nutritional supplement
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • increase in serum albumin [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • increase in lean body mass [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: May 2005
Study Completion Date: December 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Nepro nutritional supplement
oral nutritional supplement (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 480 calories: 71 calories from protein, 206 calories from carbohydrates and 206 calories from fat.
Placebo Comparator: 2 Drug: placebo
oral placebo (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 60 calories: 0 calories from protein, 60 calories from carbohydrates, and 0 calories from fat.

  Eligibility

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

Inclusion Criteria:

  1. On hemodialysis for more than 6 months
  2. Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V > 1.2)

  3. Suboptimal nutritional status identified by:

    • Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:

      • Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling 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 over the past 6 months and/or patients who are less than 90% of standard body weight

      • Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements over the consecutive two months prior to inclusion:

        • Serum transferrin concentration less than 225 mg/dl
        • Serum prealbumin concentration less than 32 mg/dl

Exclusion Criteria:

  1. Active auto-immune, inflammatory or infectious disease
  2. Documented malignancy within the last 12 months
  3. Patients on unusual dietary restrictions
  4. Life-expectancy less than 6 months
  5. Inability to tolerate nutritional supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179205

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Ross Laboratories
Investigators
Principal Investigator: Alp Ikizler, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179205     History of Changes
Other Study ID Numbers: 50006
Study First Received: September 13, 2005
Last Updated: August 5, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013