- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00047983
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
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland School of Medicine
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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No Intervention: Control
Controls and will receive no dietary supplements
|
|
Experimental: Arginine and Canola Oil
Daily nutritional supplements of arginine and canola oil
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Experimental: Arginine and Coromega
Daily nutritional supplements of arginine and Coromega
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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Compliance rates observed in each of the three study groups
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Collaborators and Investigators
Investigators
- Principal Investigator: J. W. Alexander, MD, University of Cincinnati
Publications and helpful links
General Publications
- Bower 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.
- 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.
- Daly 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.
- Alexander 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.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAIT ID01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Individual Participant Data Set
Information identifier: SDY352Information comments: ImmPort study identifier is SDY352.
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Study Protocol
Information identifier: SDY352Information comments: ImmPort study identifier is SDY352.
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Study summary, -design, -demographics, -lab tests, -study files
Information identifier: SDY352Information 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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