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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014