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Nutrient Levels Alter Transplant Outcome

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00560014
First received: November 14, 2007
Last updated: November 16, 2007
Last verified: October 2007
History of Changes
  Purpose

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.


Condition Intervention
Chronic Renal Disease
 Dietary Supplement: Arginine and canola oil
Dietary Supplement: Coromega and Arginine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Role of Immunonutrient Levels in Preventing Complications After Renal Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Plasma and red blood cell lipid profiles [ Time Frame: Within 1 year ]
  • Plasma amino acid profiles [ Time Frame: within 1 year ]

Enrollment: 54
Study Start Date: September 1997
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: 1
Arginine and Canola oil supplemented group
 Dietary Supplement: Arginine and canola oil
Canola oil 1 tablespoon BID Arginine 9.0grams BID
Other Name: Arginaid
Experimental: 2
Arginine and Coromega
 Dietary Supplement: Coromega and Arginine
Arginine 9.0 grams BID Coromega dose based on weight
Other Name: Arginaide
No Intervention: 3
Control

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal transplant recipient
  • Appropriate blood samples drawn and analyzed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560014

Locations
United States, District of Columbia
Washington Hospital
Washington, District of Columbia, United States, 20010
United States, North Carolina
Duke University School Of Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
University of Cincinnati
National Institutes of Health (NIH)
Investigators
Principal Investigator: J. W. Alexander, M.D. UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
  More Information

No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00560014     History of Changes
Other Study ID Numbers: LIPIDS, R03 AI142743, 5 U01 AI40167
Study First Received: November 14, 2007
Last Updated: November 16, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013