Clinical trial NCT03280615: Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Official title: Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Insufficiency, Chronic
Keywords: Albuminuria
Carotid Intima-Media Thickness
Pulse Wave Velocity
Inflammation
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Servicio de Salud Metropolitano Oriente
First posted: 2017-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly selected to receive 3.7 g of a supplement containing docosahexanoic and eicosapentanoic acids or a supplement containing corn oil. The supplements will be provided for 12 weeks
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a Urine Albumin Excretion Decrease of 20% or More
timeFrame: At baseline and 12 weeks of intervention
Secondary outcomes:
measure: Change in C Reactive Protein Levels at 12 Weeks of Intervention
timeFrame: At baseline and 12 weeks of intervention
measure: Change in Pulse Wave Velocity at 12 Weeks of Intervention
timeFrame: At baseline and 12 weeks of intervention
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Institute of Nutrition and Food Technology University of Chile
state: Metropolitana
Study officials:
References:
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.
citation: 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.
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.
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.
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. doi: 10.1186/s12882-016-0371-y.