Phase 3
N=100
Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Renal Insufficiency, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03280615 ↗Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With a Urine Albumin Excretion Decrease of 20% or More — 19; 13 Participants — p=0.257
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omega 3 fatty acids (Dietary_supplement); Corn oil (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chile
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Urine Albumin Excretion Decrease of 20% or More |
19; 13 | 0.257 |
| SECONDARY Change in C Reactive Protein Levels at 12 Weeks of Intervention |
3.3; 1.7; 2.1; 1.9 | 0.231 |
| SECONDARY Change in Pulse Wave Velocity at 12 Weeks of Intervention |
9.8; 9.3; 10.1; 9.7 | 0.043 sig |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03280615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.