NCT00047983

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Canola oil
DIETARY_SUPPLEMENT	Arginine
DIETARY_SUPPLEMENT	Fish oil emulsion

Timeline

• Completion: 2004-04-01
• First posted: 2002-10-24
• Last updated: 2017-01-11

Locations

4 sites across 1 country: United States