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Completed

NCT Number: NCT00047983

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

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.

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington Hospital Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Canola oil

Dietary Supplement

Arginine

Dietary Supplement

Fish oil emulsion

Dietary Supplement

Other names: Coromega

Primary outcomes

  1. 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 outcomes

  1. Compliance rates observed in each of the three study groups

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

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Registry information

Official study title

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

Important dates

Study completion
2004
First posted
Oct 24, 2002
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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