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Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179153
First Posted: September 15, 2005
Last Update Posted: May 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University
  Purpose
We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.

Condition Intervention Phase
End Stage Renal Disease Dietary Supplement: Nepro nutritional supplement Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee

Resource links provided by NLM:


Further study details as provided by Alp Ikizler, Vanderbilt University:

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

Enrollment: 352
Study Start Date: February 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Dietary Supplement: Nepro nutritional supplement
oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On CHD dialysis for more than 6 months
  • Adequately dialyzed (Kt/V > 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V > 1.0 but < 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study.
  • Suboptimal nutritional status identified by one of the following criteria:

    1. Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 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 ideal body weight.
    3. Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion:

      1. Serum albumin less than 4.0 g/dl
      2. Serum transferrin concentration less than 250 mg/dl
      3. Serum prealbumin concentration less than 32 mg/dl
    4. Subjective Global Assessment Score less than 5.

Exclusion Criteria:

  • Intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available)
  • Refusal to sign a consent form
  • On nutritional supplementation (IDPN or PO) within 2 weeks of the study initiation.
  Contacts and Locations
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): NCT00179153


Locations
United States, Tennessee
National Kidney Foundation
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Alp Ikizler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00179153     History of Changes
Other Study ID Numbers: 040345
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: May 29, 2014
Last Verified: May 2014

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