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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047983
First Posted: October 24, 2002
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
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.

Condition Intervention Phase
Kidney Diseases Dietary Supplement: Canola oil Dietary Supplement: Arginine Dietary Supplement: Fish oil emulsion Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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:
  • Compliance rates observed in each of the three study groups

Estimated Enrollment: 75
Study Completion Date: April 2004
Arms Assigned Interventions
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: Canola oil Dietary Supplement: Arginine
Experimental: Arginine and Coromega
Daily nutritional supplements of arginine and Coromega
Dietary Supplement: Arginine Dietary Supplement: Fish oil emulsion
Other Name: Coromega

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047983


Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: J. W. Alexander, MD University of Cincinnati
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY352
ImmPort study identifier is SDY352.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SDY352
ImmPort study identifier is SDY352.
Study summary, -design, -demographics, -lab tests, -study files  This link exits the ClinicalTrials.gov site
Identifier: SDY352
ImmPort study identifier is SDY352.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00047983     History of Changes
Other Study ID Numbers: DAIT ID01
First Submitted: October 23, 2002
First Posted: October 24, 2002
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney Transplantation
Fatty Acids, Omega-3
Erythrocyte Membrane
Graft Survival

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases