Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2018-10-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Identical sachets containind the study supplement or corn oil will be number coded and provided to participants

Study Groups

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Omega 3 fatty acids

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

Group Type EXPERIMENTAL

Omega 3 fatty acids

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Corn oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Corn oil

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No