Effects of marine n-3 fatty acid supplementation in renal transplantation: a randomized controlled trial.
Eide IA, Reinholt FP et al.Am J Transplant. 2018; [record in progress].
Aims
A randomized, double blind, controlled trial to evaluate whether daily supplementation of marine n-3 FAs post transplantation would improve renal function beyond standard care in renal transplant recipients.
Interventions
At 8 weeks post transplant, RT recipients received either marine n-3 FAs or olive oil (control) daily for 44 weeks, in addition to standard care. Most patients were treated according to the standard immunosuppressive protocol.
Participants
132 renal transplant recipients (≥ 18 years; eGFR > 30 mL/min/1.73m2 at 6 – 8 weeks posttransplant; a kidney donor ≤ 75 years). Patients were randomly allocated to either marine n-3 FAs (n=66) or control oil (n=66).
Outcomes
The primary endpoint was absolute change in measured GFR during follow-up. Secondary renal endpoints were renal graft histopathological indices Chronic Allograft Damage Index (CADI), percent graft inflammation and percent interstitial fibrosis. Secondary cardiovascular endpoints were flow mediated dilation, HDL, LDL and total cholesterol levels. Assessments were carried out at 8 weeks posttransplant (baseline) and one year posttransplant (study end).
Follow-up
44 weeks
CET Conclusions
This well-conducted study was adequately randomised and blinded such that the participants and investigators were kept unaware of their group allocation. Participants were randomised to receive a thrice-daily dose of either marine n-3 fatty acid, or olive oil, delivered in identical capsules in addition to standard care. The study was powered for an absolute difference of 8ml/min in GFR over the 44-week follow up period. A dropout rate of 20% was assumed, it was 23% in the end. The authors report that there was no significant difference in the change in renal function over the course of the follow up period between the two arms. There was no significant difference in renal graft fibrosis, or blood pressure. There was however, a significantly lower serum triglyceride level in the study arm by the end of the follow up. Both groups were associated with similar rates of gastrointestinal discomfort (26-32%).
Data analysis
Available case analysis
Trial registration
ClinicalTrials.gov - NCT01744067