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Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Primary Purpose

Renal Insufficiency, Chronic

Status
Completed
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Omega 3 fatty acids
Corn oil
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Albuminuria, Carotid Intima-Media Thickness, Pulse Wave Velocity, Inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Nutrition and Food Technology University of Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega 3 fatty acids

Corn oil

Arm Description

Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks

Supplementation of 3.7 g of corn oil per day during 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in C Reactive Protein Levels at 12 Weeks of Intervention
Blood C reactive protein measured at baseline and the end of the 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

Full Information

First Posted
August 8, 2017
Last Updated
July 30, 2019
Sponsor
University of Chile
Collaborators
Servicio de Salud Metropolitano Oriente
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1. Study Identification

Unique Protocol Identification Number
NCT03280615
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Servicio de Salud Metropolitano Oriente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
Albuminuria, Carotid Intima-Media Thickness, Pulse Wave Velocity, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigator
Masking Description
Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega 3 fatty acids
Arm Type
Experimental
Arm Description
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
Arm Title
Corn oil
Arm Type
Placebo Comparator
Arm Description
Supplementation of 3.7 g of corn oil per day during 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3 fatty acids
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn oil
Intervention Description
Corn oil will be the placebo comparator for omega 3 fatty acids supplement
Primary Outcome Measure Information:
Title
Number of Participants With a Urine Albumin Excretion Decrease of 20% or More
Description
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
Time Frame
At baseline and 12 weeks of intervention
Secondary Outcome Measure Information:
Title
Change in C Reactive Protein Levels at 12 Weeks of Intervention
Description
Blood C reactive protein measured at baseline and the end of the intervention.
Time Frame
At baseline and 12 weeks of intervention
Title
Change in Pulse Wave Velocity at 12 Weeks of Intervention
Description
Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s
Time Frame
At baseline and 12 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institute of Nutrition and Food Technology University of Chile
City
Santiago
State/Province
Metropolitana
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Sharing of information must be discussed with the sponsor
Citations:
PubMed Identifier
21135888
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.
Results Reference
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PubMed Identifier
27871238
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.
Results Reference
background
PubMed Identifier
28008943
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.
Results Reference
background
PubMed Identifier
25104273
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.
Results Reference
background
PubMed Identifier
27756237
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.
Results Reference
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Omega 3 Fatty Acids in Patients With Chronic Renal Disease

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