Omega 3 Fatty Acids in Patients With Chronic Renal Disease

University of Chile

Status and phase: Completed; Phase 3

Conditions: Renal Insufficiency, Chronic

Treatments: Dietary Supplement: Omega 3 fatty acids; Dietary Supplement: Corn oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03280615

Omegarenal

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Omega 3 fatty acids

Experimental group

Description:

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

Treatment:

Dietary Supplement: Omega 3 fatty acids

Corn oil

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Corn oil