Renal Insufficiency, ChronicPhase 3NCT03280615
Omega 3 Fatty Acids in Patients With Chronic Renal Disease
A Phase 3 study testing Omega 3 fatty acids and Corn oil in people with Renal Insufficiency, Chronic, run by University of Chile at 1 site in Chile.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Omega 3 fatty acids and Corn oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 20 Sep 2017to 31 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Chile1 site
Institute of Nutrition and Food Technology University of Chile
Santiago, Santiago Metropolitan
About this study
Official title: Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease
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
Read the 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:
- Urine albumin excretion
- Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin
- Carotid intima media thickness and pulse wave velocity
- Inflammation status assessed measuring serum levels of C reactive protein and interleukin 6
- Metabolic control of diabetes
- Serum lipid levels
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Omega 3 fatty acids, Corn oil
- Keywords
- Albuminuria, Carotid Intima-Media Thickness, Pulse Wave Velocity, Inflammation
- Medical subject headings
- Renal Insufficiency, Chronic, Albuminuria, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acidsDietary 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 oilDietary supplement
Corn oil will be the placebo comparator for omega 3 fatty acids supplement
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 fatty acids | Experimental | Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks Receives: Dietary Supplement: Omega 3 fatty acids |
| Corn oil | Placebo comparator | Supplementation of 3.7 g of corn oil per day during 12 weeks Receives: Dietary Supplement: Corn oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and 12 weeks of intervention
Secondary outcomes (2)
Change in C Reactive Protein Levels at 12 Weeks of Intervention
Blood C reactive protein measured at baseline and the end of the intervention.
Measured: 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
Measured: At baseline and 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start20 Sep 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio de Salud Metropolitano Sur Oriente
- Responsible party
- Principal investigator, Daniel Bunout, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280615
- Sponsor's protocol ID
- Omegarenal
- Status last verified
- Jul 2019
- First submitted
- 8 Aug 2017
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of information must be discussed with the sponsor
Publications
Shapiro H, Theilla M, Attal-Singer J, Singer P. Effects of polyunsaturated fatty acid consumption in diabetic nephropathy. Nat Rev Nephrol. 2011 Feb;7(2):110-21. doi: 10.1038/nrneph.2010.156. Epub 2010 Dec 7.
PubMed 21135888Borg M, Svensson M, Povlsen JV, Schmidt EB, Aalkjaer C, Christensen JH, Ivarsen P. Long chain n-3 polyunsaturated fatty acids and vascular function in patients with chronic kidney disease and healthy subjects: a cross-sectional and comparative study. BMC Nephrol. 2016 Nov 21;17(1):184. doi: 10.1186/s12882-016-0393-5.
PubMed 27871238Xu T, Sun Y, Sun W, Yao L, Sun L, Liu L, Ma J, Wang L. Effect of omega-3 fatty acid supplementation on serum lipids and vascular inflammation in patients with end-stage renal disease: a meta-analysis. Sci Rep. 2016 Dec 23;6:39346. doi: 10.1038/srep39346.
PubMed 28008943Hoogeveen EK, Geleijnse JM, Kromhout D, Stijnen T, Gemen EF, Kusters R, Giltay EJ. Effect of omega-3 fatty acids on kidney function after myocardial infarction: the Alpha Omega Trial. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1676-83. doi: 10.2215/CJN.10441013. Epub 2014 Aug 7.
PubMed 25104273Malhotra R, Cavanaugh KL, Blot WJ, Ikizler TA, Lipworth L, Kabagambe EK. Dietary polyunsaturated fatty acids and incidence of end-stage renal disease in the Southern Community Cohort Study. BMC Nephrol. 2016 Oct 18;17(1):152. doi: 10.1186/s12882-016-0371-y.
PubMed 27756237
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease
- ClinicalTrials.gov ID
- NCT03280615
- Acronym / sponsor ID
- Omegarenal
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Albuminuria, Carotid Intima-Media Thickness, Pulse Wave Velocity, Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Servicio de Salud Metropolitano Sur Oriente
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Urine albumin excretion
- Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin
- Carotid intima media thickness and pulse wave velocity
- Inflammation status assessed measuring serum levels of C reactive protein and interleukin 6
- Metabolic control of diabetes
- Serum lipid levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Omega 3 fatty acids | Experimental | Dietary Supplement: Omega 3 fatty acidsSupplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks |
| Corn oil | Placebo comparator | Dietary Supplement: Corn oilSupplementation of 3.7 g of corn oil per day during 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 fatty acidsOmega 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 | Dietary supplement | Omega 3 fatty acids |
| Corn oilCorn oil will be the placebo comparator for omega 3 fatty acids supplement | Dietary supplement | Corn oil |
Primary outcome
Number of Participants With a Urine Albumin Excretion Decrease of 20% or More
Time frame: 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
2 secondary outcomes
Change in C Reactive Protein Levels at 12 Weeks of Intervention
Time frame: At baseline and 12 weeks of intervention
Change in Pulse Wave Velocity at 12 Weeks of Intervention
Time frame: At baseline and 12 weeks of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21135888Shapiro H, Theilla M, Attal-Singer J, Singer P. Effects of polyunsaturated fatty acid consumption in diabetic nephropathy. Nat Rev Nephrol. 2011 Feb;7(2):110-21. doi: 10.1038/nrneph.2010.156. Epub 2010 Dec 7.
- Background: PubMed 27871238Borg M, Svensson M, Povlsen JV, Schmidt EB, Aalkjaer C, Christensen JH, Ivarsen P. Long chain n-3 polyunsaturated fatty acids and vascular function in patients with chronic kidney disease and healthy subjects: a cross-sectional and comparative study. BMC Nephrol. 2016 Nov 21;17(1):184. doi: 10.1186/s12882-016-0393-5.
- Background: PubMed 28008943Xu T, Sun Y, Sun W, Yao L, Sun L, Liu L, Ma J, Wang L. Effect of omega-3 fatty acid supplementation on serum lipids and vascular inflammation in patients with end-stage renal disease: a meta-analysis. Sci Rep. 2016 Dec 23;6:39346. doi: 10.1038/srep39346.
- Background: PubMed 25104273Hoogeveen EK, Geleijnse JM, Kromhout D, Stijnen T, Gemen EF, Kusters R, Giltay EJ. Effect of omega-3 fatty acids on kidney function after myocardial infarction: the Alpha Omega Trial. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1676-83. doi: 10.2215/CJN.10441013. Epub 2014 Aug 7.
- Background: PubMed 27756237Malhotra R, Cavanaugh KL, Blot WJ, Ikizler TA, Lipworth L, Kabagambe EK. Dietary polyunsaturated fatty acids and incidence of end-stage renal disease in the Southern Community Cohort Study. BMC Nephrol. 2016 Oct 18;17(1):152. doi: 10.1186/s12882-016-0371-y.
- Individual participant dataSharing planned: Undecided. Sharing of information must be discussed with the sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega 3 fatty acids and Corn oil in people with Renal Insufficiency, Chronic, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Urine Albumin Excretion Decrease of 20% or More (time frame: At baseline and 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280615, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.