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Completed

NCT Number: NCT03280615

Omega 3 Fatty Acids in Patients With Chronic Renal Disease

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Nutrition and Food Technology University of Chile

Santiago, Santiago Metropolitan, Chile

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

corn oil

Dietary Supplement

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

Primary outcomes

  1. Number of Participants With a Urine Albumin Excretion Decrease of 20% or More

    Time frame: At baseline and 12 weeks of intervention

    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 outcomes

  1. Change in C Reactive Protein Levels at 12 Weeks of Intervention

    Time frame: At baseline and 12 weeks of intervention

    Blood C reactive protein measured at baseline and the end of the intervention.

  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 measured at baseline and end of follow up and expressed ad m/s

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Servicio de Salud Metropolitano Oriente

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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