Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients

January 10, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients

The purpose of this study is to evaluate the effectiveness of nutritional supplements in increasing the amount of omega-3 fatty acids (and arginine) in the red blood cell membranes and plasma of kidney transplant patients, and, secondarily, to compare patient compliance. The long-term goal of this study is to develop low risk therapies that will allow improved and lasting survival of donor tissue with minimal suppression of the immune system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Short-term survival rates of donor tissue after kidney transplantation have improved significantly in recent years because of improved immunosuppression. Rates of long-term tissue loss have changed less because of a high incidence of chronic rejection, infectious complications, and cardiovascular disease. Data suggest that both early and late complications might be reduced in transplant recipients by dietary intervention to raise levels of omega-3 fatty acids and arginine.

Prior to transplantation, participants are randomized to one of three groups. Group 1 participants serve as controls and receive no dietary supplements. Participants in Group 2 receive daily nutritional supplements of arginine and canola oil according to body weight. Group 3 participants receive daily nutritional supplements of arginine and a fish oil emulsion according to body weight. All participants receive a standard, low-fat dietary consultation. The status of participants is evaluated peri-transplant and at 1, 3, 6, and 9 months.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • End-stage renal disease.
  • Candidate to receive a living-related donor, living unrelated donor, or first cadaver kidney with at least 1 HLA mismatch.
  • Negative crossmatch with the intended donor.
  • Adults must have moderate to severe hypertension and/or take at least 1 medication for hypertension daily.
  • Willingness to comply with the dietary supplements, including canola oil, a flavored drink mix, or an orange flavored pudding.

Exclusion Criteria:

  • Pregnancy or breast-feeding.
  • Women of childbearing age who are not willing or able to practice acceptable methods of contraception.
  • HIV-positive.
  • Positive test for HBV E-AG/DNA and HCV.
  • Received an organ transplant or plan to receive a multiple organ transplant.
  • Phenylketonuria.
  • Participation in other investigational studies within 30 days of the renal transplant.
  • Allergy or anaphylactic reactions to eggs or L-arginine.
  • ABO blood incompatibility.
  • Children who have previously received more than 5 blood transfusions.
  • History of stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Controls and will receive no dietary supplements
Experimental: Arginine and Canola Oil
Daily nutritional supplements of arginine and canola oil
Dietary supplement: Arginine
Dietary supplement: Canola oil
Experimental: Arginine and Coromega
Daily nutritional supplements of arginine and Coromega
Dietary supplement: Arginine
Dietary supplement: Fish oil emulsion
Other Names:
  • Coromega

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Increases in omega-3 fatty acid levels in plasma and red blood cell membranes observed in each of the three omega-3 supplements used in this study

Secondary Outcome Measures

Outcome Measure
Compliance rates observed in each of the three study groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: J. W. Alexander, MD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

October 23, 2002

First Submitted That Met QC Criteria

October 23, 2002

First Posted (Estimate)

October 24, 2002

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT ID01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: SDY352
    Information comments: ImmPort study identifier is SDY352.
  2. Study Protocol
    Information identifier: SDY352
    Information comments: ImmPort study identifier is SDY352.
  3. Study summary, -design, -demographics, -lab tests, -study files
    Information identifier: SDY352
    Information comments: ImmPort study identifier is SDY352.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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