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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Controls and will receive no dietary supplements | |
| Arginine and Canola Oil | Experimental | Daily nutritional supplements of arginine and canola oil |
|
| Arginine and Coromega | Experimental | Daily nutritional supplements of arginine and Coromega |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canola oil | Dietary Supplement |
| ||
| Arginine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance rates observed in each of the three study groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. W. Alexander, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| University of Maryland School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8350886 | Background | 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. | |
| 1377838 | Background | 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. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SDY352 | Individual Participant Data Set | View IPD |
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.
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000074262 | Rapeseed Oil |
| D001120 | Arginine |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 |
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|
| Fish oil emulsion | Dietary Supplement |
|
|
| 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 |
| 7874893 | Background | 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. |
| 9586793 | Background | 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. |
| 39082471 | Derived | Natale 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. |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
ImmPort study identifier is SDY352. |
| SDY352 | Study Protocol | View IPD | ImmPort study identifier is SDY352. |
| SDY352 | Study summary, -design, -demographics, -lab tests, -study files | View IPD | ImmPort study identifier is SDY352. |
| D052801 | Male Urogenital Diseases |
| Biological Products |
| D045424 | Complex Mixtures |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |