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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Early Phase 1

Conditions: Kidney Diseases

Treatments: Dietary Supplement: Fish oil emulsion; Dietary Supplement: Canola oil; Dietary Supplement: Arginine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00047983

DAIT ID01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Control

No Intervention group

Description:

Controls and will receive no dietary supplements

Arginine and Canola Oil

Experimental group

Description:

Daily nutritional supplements of arginine and canola oil

Treatment:

Dietary Supplement: Arginine

Dietary Supplement: Canola oil

Arginine and Coromega

Experimental group

Description:

Daily nutritional supplements of arginine and Coromega

Treatment:

Dietary Supplement: Arginine

Dietary Supplement: Fish oil emulsion