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Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT00179205
Recruitment Status : Terminated (funding exhausted)
First Posted : September 15, 2005
Last Update Posted : August 6, 2008
Sponsor:
Collaborator:
Ross Laboratories
Information provided by:
Vanderbilt University

Brief Summary:
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 or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Nepro nutritional supplement Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Complementary Intradialytic Nutritional Supplementation in Dialysis Patients
Study Start Date : May 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. increase in serum albumin [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. increase in lean body mass [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179205     History of Changes
Other Study ID Numbers: 50006
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: August 2008

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