Nutrient Levels Alter Transplant Outcome

Not Applicable

Completed

• Conditions: Chronic Renal Disease
• Interventions: Dietary Supplement: Coromega and Arginine; Dietary Supplement: Arginine and canola oil

• Registration Number: NCT00560014
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-09
• Study Completion: 2005-05
• Status Verified: 2007-10
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-16
• Last Update Submitted: 2007-11-16
• Study First Posted: 2007-11-19
• Last Update Posted: 2007-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Renal transplant recipient
• Appropriate blood samples drawn and analyzed

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	Coromega and Arginine	Arginine and Coromega
1	Arginine and canola oil	Arginine and Canola oil supplemented group

Primary Outcome Measures

Name	Time	Method
Plasma and red blood cell lipid profiles	Within 1 year
Plasma amino acid profiles	within 1 year

Trial Locations

Locations (2)

Duke University School Of Medicine; 🇺🇸 Durham, North Carolina, United States

Washington Hospital; 🇺🇸 Washington, District of Columbia, United States