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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:
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179153
First received: September 13, 2005
Last updated: May 27, 2014
Last verified: May 2014
  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: 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 Vanderbilt University:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Alp Ikizler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00179153     History of Changes
Other Study ID Numbers: 040345
Study First Received: September 13, 2005
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014