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Nutrient Levels Alter Transplant Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00560014
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : November 19, 2007
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment
Chronic Renal Disease Dietary Supplement: Arginine and canola oil Dietary Supplement: Coromega and Arginine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role of Immunonutrient Levels in Preventing Complications After Renal Transplantation
Study Start Date : September 1997
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal transplant recipient
  • Appropriate blood samples drawn and analyzed
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
5U01AI040167 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: November 19, 2007
Last Verified: October 2007

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