Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nepro nutritional supplement

placebo

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: On hemodialysis for more than 6 months Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V > 1.2) 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: Active auto-immune, inflammatory or infectious disease Documented malignancy within the last 12 months Patients on unusual dietary restrictions Life-expectancy less than 6 months Inability to tolerate nutritional supplements

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

increase in serum albumin

Secondary Outcome Measures

increase in lean body mass

Full Information

NCT ID

NCT00179205

First Posted

September 13, 2005

Last Updated

August 5, 2008

Sponsor

Vanderbilt University

Collaborators

Ross Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00179205

Brief Title

Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Official Title

Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Terminated

Why Stopped

funding exhausted

Study Start Date

May 2005 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vanderbilt University

Collaborators

Ross Laboratories

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Active Comparator

Arm Title

2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Nepro nutritional supplement

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

increase in serum albumin

Time Frame

6 months

Secondary Outcome Measure Information:

Title

increase in lean body mass

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: On hemodialysis for more than 6 months Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V > 1.2) 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: Active auto-immune, inflammatory or infectious disease Documented malignancy within the last 12 months Patients on unusual dietary restrictions Life-expectancy less than 6 months Inability to tolerate nutritional supplements

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alp Ikizler, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32390133

Citation

Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.

Results Reference

derived

End Stage Renal Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial