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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

September 13, 2005
May 27, 2014
February 2005
May 2009   (final data collection date for primary outcome measure)
increase in serum albumin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179153
040345
No
Alp Ikizler, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Vanderbilt University
May 2014

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