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Nutrient Levels Alter Transplant Outcome

Primary Purpose

Chronic Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arginine and canola oil
Coromega and Arginine
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Renal Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Renal transplant recipient
  • Appropriate blood samples drawn and analyzed

Sites / Locations

  • Washington Hospital
  • Duke University School Of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

Arginine and Canola oil supplemented group

Arginine and Coromega

Control

Outcomes

Primary Outcome Measures

Plasma and red blood cell lipid profiles
Plasma amino acid profiles

Secondary Outcome Measures

Full Information

First Posted
November 14, 2007
Last Updated
November 16, 2007
Sponsor
University of Cincinnati
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00560014
Brief Title
Nutrient Levels Alter Transplant Outcome
Official Title
Role of Immunonutrient Levels in Preventing Complications After Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cincinnati
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to look at lipid profiles of plasma and RBC and amino acid profiles in plasma to determine if they are associated with allograft rejection, calcineurin inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving dietary supplements with arginine and omega-3 fatty acids.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Arginine and Canola oil supplemented group
Arm Title
2
Arm Type
Experimental
Arm Description
Arginine and Coromega
Arm Title
3
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Dietary Supplement
Intervention Name(s)
Arginine and canola oil
Other Intervention Name(s)
Arginaid
Intervention Description
Canola oil 1 tablespoon BID Arginine 9.0grams BID
Intervention Type
Dietary Supplement
Intervention Name(s)
Coromega and Arginine
Other Intervention Name(s)
Arginaide
Intervention Description
Arginine 9.0 grams BID Coromega dose based on weight
Primary Outcome Measure Information:
Title
Plasma and red blood cell lipid profiles
Time Frame
Within 1 year
Title
Plasma amino acid profiles
Time Frame
within 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Renal transplant recipient Appropriate blood samples drawn and analyzed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. W. Alexander, M.D.
Organizational Affiliation
UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Duke University School Of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18816238
Citation
Alexander JW, Goodman HR, Succop P, Light JA, Kuo PC, Moser AB, James JH, Woodle ES. Influence of long chain polyunsaturated fatty acids and ornithine concentrations on complications after renal transplant. Exp Clin Transplant. 2008 Jun;6(2):118-26.
Results Reference
derived

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Nutrient Levels Alter Transplant Outcome

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