Omega 3 Fatty Acids in Patients With Chronic Renal Disease

NCT03280615 | Completed Phase 3 Results DMC

• 1 other identifier: Omegarenal
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Insufficiency, Chronic

Keywords

Albuminuria; Carotid Intima-Media Thickness; Pulse Wave Velocity; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in C Reactive Protein Levels at 12 Weeks of Intervention

  At baseline and 12 weeks of intervention

• Change in Pulse Wave Velocity at 12 Weeks of Intervention

  At baseline and 12 weeks of intervention

Study Arms (2)

Omega 3 fatty acids

EXPERIMENTAL

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

Dietary Supplement: Omega 3 fatty acids

Corn oil

PLACEBO COMPARATOR

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

Dietary Supplement: Corn oil

Interventions

Omega 3 fatty acids DIETARY_SUPPLEMENT

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

Omega 3 fatty acids

Corn oil DIETARY_SUPPLEMENT

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

Corn oil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Servicio de Salud Metropolitano Oriente: collaborator

Study Sites (1)

Institute of Nutrition and Food Technology University of Chile

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (5)

• 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.

  PMID: 21135888 BACKGROUND

• 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.

  PMID: 27871238 BACKGROUND

• 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.

  PMID: 28008943 BACKGROUND

• 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.

  PMID: 25104273 BACKGROUND

• 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.

  PMID: 27756237 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Albuminuria; Inflammation

Interventions

Fatty Acids, Omega-3; Corn Oil

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Francisco Perez Bravo, Director
• Organization: Institute of Nutrition and Food Technology University of Chile

fperez@inta.uchile.cl

+5629781411

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full profesor

Model Details: 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

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: September 12, 2017
• Study Start: September 20, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-07

Locations

CL (1)