Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.
There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients. This study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients. 8 weeks after transplantation, if renal function has stabilized, patients with a eGFR\>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)
Placebo capsules 3 times a day (oral administration)
Oslo University Hospital Rikshospitalet
Oslo, * Other, Norway
Oslo University Hospital, Rikshospitalet
Oslo, Oslo County, Norway
Glomerular filtration rate
Iohexol clearance
Time frame: 44 weeks
Proteinuria
Both ACR and FEPR
Time frame: 44 weeks
Inflammation in the renal transplant
Degree of total inflammation in renal transplant biopsies, scores by PI and rescored by two pathologists.
Time frame: 44 weeks
Fibrosis in the renal transplant
As for inflammation
Time frame: 44 weeks
Blood pressure
Time frame: 44 weeks
Heart rate variability
Time frame: 44 weeks
Flow mediated dilation
Time frame: 44 weeks
Pulse wave velocity and augmentation index
Time frame: 44 weeks
Blood glucose
HbA1c and oral glucose tolerance test
Time frame: 44 weeks
Lipids
Total, LDL and HDL cholesterol, triglycerid and ratios
Time frame: 44 weeks
Body composition
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Visceral fat volume and weight, visceral to subcutaneous fat ratio.
Time frame: 44 weeks
Bone mineral density
Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.
Time frame: 44 weeks
Body mass index
Time frame: 44 weeks
Vitamin D levels
Time frame: 44 weeks
Fatty acid composition in plasma and renal tissue
Time frame: 44 weeks
Tacrolimus pharmacokinetics
Substudy of 15 patients, where we study tacrolimus trough levels, Tmax and AUC at the end of the ORENTRA trial, after a minimum of 4 weeks wash-out and again after 4 weeks of 2.7 g omega-3 fatty acid supplementation
Time frame: 12 weeks