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Omega 3 Fatty Acids in Patients With Chronic Renal Disease

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ClinicalTrials.gov Identifier: NCT03280615
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
Servicio de Salud Metropolitano Oriente
Information provided by (Responsible Party):
Daniel Bunout, University of Chile

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

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Dietary Supplement: Omega 3 fatty acids Dietary Supplement: Corn oil Phase 3

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
Primary Purpose: Treatment
Official Title: Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Urine albumin excretion at 12 weeks of intervention [ Time Frame: At baseline and 12 weeks of intervention ]
    Measurement of albumin excretion in a 24 hour urine sample


Secondary Outcome Measures :
  1. Change in C reactive protein levels at 12 weeks of intervention [ Time Frame: At baseline and 12 weeks of intervention ]
    Measurement of c reactive protein in blood samples

  2. Change in Pulse wave velocity at 12 weeks of intervention [ Time Frame: At baseline and 12 weeks of intervention ]
    Measurement of pulse wave velocity using a oscillometric device



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280615


Contacts
Contact: Veronica Cornejo, MSc +56229781411 vcornejo@inta.uchile.cl
Contact: Ana Maria Pino, MSc +56221897814 ampino@inta.uchile.cl

Locations
Chile
Institute of Nutrition and Food Technology University of Chile Recruiting
Santiago, Metropolitana, Chile
Contact: Veronica Cornejo, MSc    +56229781411    vcornejo@inta.uchile.cl   
Contact: Patricio Peirano, MD    +562291781411    ppeirano@inta.uchile.cl   
Sponsors and Collaborators
University of Chile
Servicio de Salud Metropolitano Oriente

Publications:
Responsible Party: Daniel Bunout, Full profesor, University of Chile
ClinicalTrials.gov Identifier: NCT03280615     History of Changes
Other Study ID Numbers: Omegarenal
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Sharing of information must be discussed with the sponsor

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Bunout, University of Chile:
Albuminuria
Carotid Intima-Media Thickness
Pulse Wave Velocity
Inflammation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases