Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease

To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and vascular function and inflammatory parameters in patients with chronic renal disease

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Dietary supplement: Omega 3 fatty acids; Dietary supplement: Corn oil

Detailed Description

In a double blind trial in patients with chronic renal disease, the effects of a 3.7 g supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of corn oil during 12 weeks, will be assessed on the following parameters:

1. Urine albumin excretion
2. Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin
3. Carotid intima media thickness and pulse wave velocity
4. Inflammation status assessed measuring serum levels of C reactive protein and interleukin 6
5. Metabolic control of diabetes
6. Serum lipid levels

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile
      • Institute of Nutrition and Food Technology University of Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Urinary albumin excretion over 30 mg/g creatinin
• Chronic renal failure stage 2 to 4
• Absence of serious conditions such as cáncer, decompensated heart failure, chronic infections and severe arterial lesions

Exclusion Criteria:

• Blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8%
• Presence of cognitive impairment that does not allow to sigin a written informed consent
• Alcohol or illicit drug abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega 3 fatty acids; Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks	Dietary supplement: Omega 3 fatty acids; Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids
Placebo Comparator: Corn oil; Supplementation of 3.7 g of corn oil per day during 12 weeks	Dietary supplement: Corn oil; Corn oil will be the placebo comparator for omega 3 fatty acids supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Urine Albumin Excretion Decrease of 20% or More	Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more	At baseline and 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C Reactive Protein Levels at 12 Weeks of Intervention	Blood C reactive protein measured at baseline and the end of the intervention.	At baseline and 12 weeks of intervention
Change in Pulse Wave Velocity at 12 Weeks of Intervention	Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s	At baseline and 12 weeks of intervention

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Servicio de Salud Metropolitano Oriente

Publications and helpful links

General Publications

• Shapiro H, Theilla M, Attal-Singer J, Singer P. Effects of polyunsaturated fatty acid consumption in diabetic nephropathy. Nat Rev Nephrol. 2011 Feb;7(2):110-21. doi: 10.1038/nrneph.2010.156. Epub 2010 Dec 7.
• Borg M, Svensson M, Povlsen JV, Schmidt EB, Aalkjaer C, Christensen JH, Ivarsen P. Long chain n-3 polyunsaturated fatty acids and vascular function in patients with chronic kidney disease and healthy subjects: a cross-sectional and comparative study. BMC Nephrol. 2016 Nov 21;17(1):184. doi: 10.1186/s12882-016-0393-5.
• Xu T, Sun Y, Sun W, Yao L, Sun L, Liu L, Ma J, Wang L. Effect of omega-3 fatty acid supplementation on serum lipids and vascular inflammation in patients with end-stage renal disease: a meta-analysis. Sci Rep. 2016 Dec 23;6:39346. doi: 10.1038/srep39346.
• Hoogeveen EK, Geleijnse JM, Kromhout D, Stijnen T, Gemen EF, Kusters R, Giltay EJ. Effect of omega-3 fatty acids on kidney function after myocardial infarction: the Alpha Omega Trial. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1676-83. doi: 10.2215/CJN.10441013. Epub 2014 Aug 7.
• Malhotra R, Cavanaugh KL, Blot WJ, Ikizler TA, Lipworth L, Kabagambe EK. Dietary polyunsaturated fatty acids and incidence of end-stage renal disease in the Southern Community Cohort Study. BMC Nephrol. 2016 Oct 18;17(1):152. doi: 10.1186/s12882-016-0371-y.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Inflammation; Pulse Wave Velocity; Albuminuria; Carotid Intima-Media Thickness
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: Omegarenal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Sharing of information must be discussed with the sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No