Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients
A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients
1 other identifier
interventional
75
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2002
CompletedFirst Posted
Study publicly available on registry
October 24, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedJanuary 11, 2017
January 1, 2017
October 23, 2002
January 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Compliance rates observed in each of the three study groups
Study Arms (3)
Control
NO INTERVENTIONControls and will receive no dietary supplements
Arginine and Canola Oil
EXPERIMENTALDaily nutritional supplements of arginine and canola oil
Arginine and Coromega
EXPERIMENTALDaily nutritional supplements of arginine and Coromega
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
Related Publications (5)
van der Heide JJ, Bilo HJ, Donker JM, Wilmink JM, Tegzess AM. Effect of dietary fish oil on renal function and rejection in cyclosporine-treated recipients of renal transplants. N Engl J Med. 1993 Sep 9;329(11):769-73. doi: 10.1056/NEJM199309093291105.
PMID: 8350886BACKGROUNDDaly JM, Lieberman MD, Goldfine J, Shou J, Weintraub F, Rosato EF, Lavin P. Enteral nutrition with supplemental arginine, RNA, and omega-3 fatty acids in patients after operation: immunologic, metabolic, and clinical outcome. Surgery. 1992 Jul;112(1):56-67.
PMID: 1377838BACKGROUNDBower RH, Cerra FB, Bershadsky B, Licari JJ, Hoyt DB, Jensen GL, Van Buren CT, Rothkopf MM, Daly JM, Adelsberg BR. Early enteral administration of a formula (Impact) supplemented with arginine, nucleotides, and fish oil in intensive care unit patients: results of a multicenter, prospective, randomized, clinical trial. Crit Care Med. 1995 Mar;23(3):436-49. doi: 10.1097/00003246-199503000-00006.
PMID: 7874893BACKGROUNDAlexander JW, Levy A, Custer D, Valente JF, Babcock G, Ogle CK, Schroeder TJ. Arginine, fish oil, and donor-specific transfusions independently improve cardiac allograft survival in rats given subtherapeutic doses of cyclosporin. JPEN J Parenter Enteral Nutr. 1998 May-Jun;22(3):152-5. doi: 10.1177/0148607198022003152.
PMID: 9586793BACKGROUNDNatale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
PMID: 39082471DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. W. Alexander, MD
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2002
First Posted
October 24, 2002
Study Completion
April 1, 2004
Last Updated
January 11, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
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.