Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280615
• Other study ID #: Omegarenal
• Status: Completed
• Phase: Phase 3
• Start date: September 20, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: July 2019
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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
• Corn oil
Corn oil will be the placebo comparator for omega 3 fatty acids supplement

Locations

Country	Name	City	State
Chile	Institute of Nutrition and Food Technology University of Chile	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Servicio de Salud Metropolitano Oriente

Country where clinical trial is conducted

Chile, 

References & Publications (5)

Borg M, Svensson M, Povlsen JV, Schmidt EB, Aalkjær 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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