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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00560014
Other study ID # LIPIDS
Secondary ID R03 AI1427435U01
Status Completed
Phase N/A
First received November 14, 2007
Last updated November 16, 2007
Start date September 1997
Est. completion date May 2005

Study information

Verified date October 2007
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Renal transplant recipient

- Appropriate blood samples drawn and analyzed

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Dietary Supplement:
Arginine and canola oil
Canola oil 1 tablespoon BID Arginine 9.0grams BID
Coromega and Arginine
Arginine 9.0 grams BID Coromega dose based on weight

Locations

Country Name City State
United States Duke University School Of Medicine Durham North Carolina
United States Washington Hospital Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of Cincinnati National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma and red blood cell lipid profiles Within 1 year
Primary Plasma amino acid profiles within 1 year
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