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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00047983 |
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 |
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Kidney Diseases |
Drug: Canola oil Drug: Arginine Drug: Fish oil emulsion |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients |
Estimated Enrollment: | 75 |
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.
Ages Eligible for Study: | 4 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | J. W. Alexander, MD | University of Cincinnati |
Study ID Numbers: | DAIT ID01 |
Study First Received: | October 23, 2002 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00047983 |
Health Authority: | United States: Federal Government |
Kidney Transplantation Fatty Acids, Omega-3 Erythrocyte Membrane Graft Survival |
Urologic Diseases Kidney Diseases |