Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 4 - Any |
Updated: | 1/12/2017 |
End Date: | April 2004 |
A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients
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.
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.
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.
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.
We found this trial at
4
sites
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655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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