NCT00560014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 1997

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
Last Updated

November 19, 2007

Status Verified

October 1, 2007

First QC Date

November 14, 2007

Last Update Submit

November 16, 2007

Conditions

Chronic Renal Disease

Outcome Measures

Primary Outcomes (2)

  • Plasma and red blood cell lipid profiles

    Within 1 year

  • Plasma amino acid profiles

    within 1 year

Study Arms (3)

1

EXPERIMENTAL

Arginine and Canola oil supplemented group

Dietary Supplement: Arginine and canola oil

2

EXPERIMENTAL

Arginine and Coromega

Dietary Supplement: Coromega and Arginine

3

NO INTERVENTION

Control

Interventions

Arginine and canola oilDIETARY_SUPPLEMENT

Canola oil 1 tablespoon BID Arginine 9.0grams BID

Also known as: Arginaid
1
Coromega and ArginineDIETARY_SUPPLEMENT

Arginine 9.0 grams BID Coromega dose based on weight

Also known as: Arginaide
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplant recipient
  • Appropriate blood samples drawn and analyzed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Duke University School Of Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 18816238DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

ArginineRapeseed Oil

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, EssentialPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • J. W. Alexander, M.D.

    UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 19, 2007

Study Start

September 1, 1997

Study Completion

May 1, 2005

Last Updated

November 19, 2007

Record last verified: 2007-10

Locations

US(2)