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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
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
Compliance rates observed in each of the three study groups
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