Omega-3 fatty acids as immunosupressive supplement after organ transplantation - national, randomized, double-blind study.

Organ transplantation is a standard treatment of end-stage organ failure. Transplanted patients need to be life-long medicated with immunosuppressants to avoid organ rejection.

However, due to severe side effects of such treatment, innovative way of using combination of existing drugs with lower toxicity, and at least as effective immunosuppressive effect, is urgently wanted.

Our retrospective study on effect of supplementation of medication with long-chained omega-3 fatty acids early after liver transplantation, has shown reduction of acute liver rejections from 27% to 8%.

To verify this observation, we call for a National Randomized Controlled Trial in liver and kidney transplanted patients. The study will be opened for all transplant centers in Sweden (Gothenburg, Malmö, Uppsala and Stockholm).

Randomized, double-blind study will be performed based on enrolment of adult, newly liver (n=162) or kidney (n=280) transplanted patients.

Patients will be treated with standard immunosuppression protocol and get supplementation with high dose of omega-3 fatty acids daily, during the first week after transplantation, or placebo. The primary end-point of the study will be acute organ rejection during the first three months after transplantation.

As acute rejection correlates with chronic rejections, a secondary end-point of the study will include episodes of late acute or chronic rejection at the 1-year posttransplant control.