A Phase 3 interventional study of Omega 3 fatty acids and Corn oil in Renal Insufficiency, Chronic, sponsored by University of Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by University of Chile · Phase 3, Interventional, and Treatment
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
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:
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 100 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →University of Chile is the lead sponsor of 194 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
Dietary Supplement: Omega 3 fatty acids
Supplementation of 3.7 g of corn oil per day during 12 weeks
Dietary Supplement: Corn oil
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 will be the placebo comparator for omega 3 fatty acids supplement
Number of Participants With a Urine Albumin Excretion Decrease of 20% or More
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
Time frame: At baseline and 12 weeks of intervention
Change in C Reactive Protein Levels at 12 Weeks of Intervention
Blood C reactive protein measured at baseline and the end of the intervention.
Time frame: At baseline and 12 weeks of intervention
Change in Pulse Wave Velocity at 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
Time frame: At baseline and 12 weeks of intervention
| Milestone | Omega 3 Fatty Acids | Corn Oil |
|---|---|---|
| Started | 50 | 50 |
| Completed | 46 | 45 |
| Not completed | 4 | 5 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 2 |
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
| Participants | Omega 3 Fatty Acids | Corn Oil |
|---|---|---|
| Number of Participants With a Urine Albumin Excretion Decrease of 20% or More | 19 | 13 |
Blood C reactive protein measured at baseline and the end of the intervention.
| mg/L | Omega 3 Fatty Acids | Corn Oil |
|---|---|---|
| baseline | 3.3 (1.5 to 5.3) | 1.7 (1.1 to 4.1) |
| end of follow up | 2.1 (1.2 to 5.9) | 1.9 (1 to 5.2) |
Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s
| m/s | Omega 3 Fatty Acids | Corn Oil |
|---|---|---|
| baseline | 9.8 (8.1 to 10.6) | 9.3 (8.5 to 10.7) |
| end of follow up | 10.1 (8 to 10.9) | 9.7 (8.3 to 11.2) |
Collected over Three months of follow up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omega 3 Fatty Acids | 0/50 (0%) | 2/50 (4%) | 27/50 (54%) |
| Corn Oil | 0/50 (0%) | 4/50 (8%) | 48/50 (96%) |
| Event | Omega 3 Fatty Acids | Corn Oil |
|---|---|---|
| Started dialysisRenal and urinary disorders | 2/50 | 2/50 |
| HyperkalemiaRenal and urinary disorders | 0/50 | 1/50 |
| Cervical massBlood and lymphatic system disorders | 0/50 | 1/50 |
| Event | Omega 3 Fatty Acids | Corn Oil |
|---|---|---|
| Minor complaintsProduct Issues | 13/50 | 36/50 |
| Nausea, vomiting or diarrheaGastrointestinal disorders | 14/50 | 12/50 |
| Age, Continuous(years) | Omega 3 Fatty Acids | Corn Oil | Total |
|---|---|---|---|
| Median | 67 (54 to 74) | 66 (56 to 74) | 66 (57 to 74) |
| Sex: Female, Male(Participants) | Omega 3 Fatty Acids | Corn Oil | Total |
|---|---|---|---|
| Female | 23 | 26 | 49 |
| Male | 27 | 24 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Omega 3 Fatty Acids | Corn Oil | Total |
|---|---|---|---|
| Hispanic or Latino | 50 | 50 | 100 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Omega 3 Fatty Acids | Corn Oil | Total |
|---|---|---|---|
| Chile | 50 | 50 | 100 |
| Urine albumin excretion(mg/g creatinine) | Omega 3 Fatty Acids | Corn Oil | Total |
|---|---|---|---|
| Median | 363 (157 to 1030) | 541 (173 to 1125) | 455 (157 to 1079) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Sharing of information must be discussed with the sponsor
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid
Renal Insufficiency, Chronic →