Plasma Marine n-3 Polyunsaturated Fatty Acids and Patient and Graft Survival

NCT ID: NCT02017990

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2002 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2013-06-30

Brief Summary

This study will evaluate the association between n-3 polyunsaturated fatty acids and patient and graft survival. The association between other fatty acids and mortality and graft loss endpoints will also be evaluated.

Detailed Description

This observational study focuses on the effects of marine n-3 polyunsaturated fatty acids (PUFAs) intake, measured as fatty acid levels in plasma phospholipids, and mortality and graft loss endpoints in renal transplant recipients. Data on morbidity, mortality and graft loss in The Norwegian Renal Registry is matched against data on fatty acid composition in a large renal transplantation cohort of approximately 2000 patients with a median follow up time of about 5 years. It is a follow up study, although retrospectively evaluated. It will evaluate the role of marine n-3 PUFAs as a prognostic marker in renal transplantation by investigating the association between the levels (weight percentage of total fatty acids) of marine n-3 PUFAs in plasma phospholipids and events, including mortality and graft loss.

Conditions

Disorder of Transplanted Kidney

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Renal transplant recipients

No intervention. Measurements of plasma marine n-3 polyunsaturated fatty acids levels, indicating intake of fish and seafood.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Received a renal transplant. Signed informed consent.

Exclusion Criteria

• Under the age of 16 years.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivar Eide, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital, Rikshospitalet

Oslo, Oslo County, Norway

Countries

Norway

References

Eide IA, Jenssen T, Hartmann A, Diep LM, Dahle DO, Reisaeter AV, Bjerve KS, Christensen JH, Schmidt EB, Svensson M. The association between marine n-3 polyunsaturated fatty acid levels and survival after renal transplantation. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1246-56. doi: 10.2215/CJN.11931214. Epub 2015 Jun 10.

Reference Type: DERIVED

PMID: 26063768 (View on PubMed)

Other Identifiers

REK 2012/1419

Identifier Type: -

Identifier Source: org_study_id