Nutrient Levels Alter Transplant Outcome

NCT ID: NCT00560014

Last Updated: 2007-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2005-05-31

Brief Summary

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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

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Conditions

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Chronic Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Arginine and Canola oil supplemented group

Group Type EXPERIMENTAL

Arginine and canola oil

Intervention Type DIETARY_SUPPLEMENT

Canola oil 1 tablespoon BID Arginine 9.0grams BID

2

Arginine and Coromega

Group Type EXPERIMENTAL

Coromega and Arginine

Intervention Type DIETARY_SUPPLEMENT

Arginine 9.0 grams BID Coromega dose based on weight

3

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Arginine and canola oil

Canola oil 1 tablespoon BID Arginine 9.0grams BID

Intervention Type DIETARY_SUPPLEMENT

Coromega and Arginine

Arginine 9.0 grams BID Coromega dose based on weight

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Arginaid Arginaide

Eligibility Criteria

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Inclusion Criteria

* Renal transplant recipient
* Appropriate blood samples drawn and analyzed
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Principal Investigators

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J. W. Alexander, M.D.

Role: PRINCIPAL_INVESTIGATOR

UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati

Locations

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Washington Hospital

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

Site Status

Duke University School Of Medicine

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18816238 (View on PubMed)

Other Identifiers

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R03 AI142743

Identifier Type: -

Identifier Source: secondary_id

5U01AI040167

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LIPIDS

Identifier Type: -

Identifier Source: org_study_id