Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00179205
• Other study ID #: 50006
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: August 5, 2008
• Start date: May 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: December 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Nepro nutritional supplement
oral nutritional supplement (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 480 calories: 71 calories from protein, 206 calories from carbohydrates and 206 calories from fat.
• placebo
oral placebo (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 60 calories: 0 calories from protein, 60 calories from carbohydrates, and 0 calories from fat.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Ross Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase in serum albumin		6 months	No
Secondary	increase in lean body mass		6 months	No