We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
September 13, 2005
September 15, 2005
May 29, 2014
February 2005
May 2009   (Final data collection date for primary outcome measure)
increase in serum albumin [ Time Frame: 6 months ]
increase in serum albumin
Complete list of historical versions of study NCT00179153 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End Stage Renal Disease
Dietary Supplement: Nepro nutritional supplement
oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months
Active Comparator: 1
Intervention: Dietary Supplement: Nepro nutritional supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
352
May 2009
May 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00179153
040345
No
Not Provided
Not Provided
Alp Ikizler, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center
Vanderbilt University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP