Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients

Conditions
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Kidney Diseases

Intervention / Treatment
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* Dietary Supplement: Canola oil
* Dietary Supplement: Arginine
* Dietary Supplement: Fish oil emulsion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Controls and will receive no dietary supplements | |
| Experimental: Arginine and Canola Oil<br>Daily nutritional supplements of arginine and canola oil | Dietary Supplement: Canola oil<br> <br> Dietary Supplement: Arginine<br> <br> |
| Experimental: Arginine and Coromega<br>Daily nutritional supplements of arginine and Coromega | Dietary Supplement: Arginine<br> <br> Dietary Supplement: Fish oil emulsion<br> <br> * Other names: Coromega;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rates observed in each of the three study groups |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Fatty Acids, Omega-3, Erythrocyte Membrane, Graft Survival