Disorder Related to Renal Transplantation Clinical Trial
Official title:
The Effects of n-3 Polyunsaturated Fatty Acids on Renal and Cardiovascular Risk Markers in Renal Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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