Nutrient Levels Alter Transplant Outcome - Full Text View

Sponsors and Collaborators:	University of Cincinnati National Institutes of Health (NIH)
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00560014

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

MedlinePlus related topics: Dietary Supplements Kidney Transplantation Rape

Drug Information available for: Arginine Arginine hydrochloride Canola oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Factorial Assignment
Official Title:	Role of Immunonutrient Levels in Preventing Complications After Renal Transplantation

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
1: Experimental Arginine and Canola oil supplemented group	Dietary Supplement: Arginine and canola oil Canola oil 1 tablespoon BID Arginine 9.0grams BID
2: Experimental Arginine and Coromega	Dietary Supplement: Coromega and Arginine Arginine 9.0 grams BID Coromega dose based on weight
3: No Intervention 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

Publications indexed to this study:

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.

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

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 15, 2009