Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Vanderbilt University

Status and phase: Terminated; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: placebo; Drug: Nepro nutritional supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT00179205

50006

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Nepro nutritional supplement

2

Placebo Comparator group

Treatment:

Drug: placebo