Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Phase 3

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Dietary Supplement: Omega 3 fatty acids; Dietary Supplement: Corn oil

• Registration Number: NCT03280615
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-12
• Study Start: 2017-09-20
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Results First Submitted: 2019-03-29
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-30
• Last Update Submitted: 2019-07-30
• Results First Posted: 2019-09-09
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega 3 fatty acids	Omega 3 fatty acids	Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
Corn oil	Corn oil	Supplementation of 3.7 g of corn oil per day during 12 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Urine Albumin Excretion Decrease of 20% or More	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 Outcome Measures

Name	Time	Method
Change in C Reactive Protein Levels at 12 Weeks of Intervention	At baseline and 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	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

Trial Locations

Locations (1)

Institute of Nutrition and Food Technology University of Chile; 🇨🇱 Santiago, Metropolitana, Chile