Trial Outcomes & Findings for Omega 3 Fatty Acids in Patients With Chronic Renal Disease (NCT NCT03280615)
NCT ID: NCT03280615
Last Updated: 2019-09-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
At baseline and 12 weeks of intervention
Results posted on
2019-09-09
Participant Flow
Participant milestones
| Measure |
Omega 3 Fatty Acids
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
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
|
Corn Oil
Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Omega 3 Fatty Acids
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
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
|
Corn Oil
Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Baseline characteristics by cohort
| Measure |
Omega 3 Fatty Acids
n=50 Participants
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
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
|
Corn Oil
n=50 Participants
Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Urine albumin excretion
|
363 mg/g creatinine
n=5 Participants
|
541 mg/g creatinine
n=7 Participants
|
455 mg/g creatinine
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and 12 weeks of interventionNumber 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
Outcome measures
| Measure |
Omega 3 Fatty Acids
n=46 Participants
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
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
|
Corn Oil
n=45 Participants
Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: 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
|
19 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: At baseline and 12 weeks of interventionBlood C reactive protein measured at baseline and the end of the intervention.
Outcome measures
| Measure |
Omega 3 Fatty Acids
n=46 Participants
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
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
|
Corn Oil
n=45 Participants
Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement
|
|---|---|---|
|
Change in C Reactive Protein Levels at 12 Weeks of Intervention
baseline
|
3.3 mg/L
Interval 1.5 to 5.3
|
1.7 mg/L
Interval 1.1 to 4.1
|
|
Change in C Reactive Protein Levels at 12 Weeks of Intervention
end of follow up
|
2.1 mg/L
Interval 1.2 to 5.9
|
1.9 mg/L
Interval 1.0 to 5.2
|
SECONDARY outcome
Timeframe: At baseline and 12 weeks of interventionMeasurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s
Outcome measures
| Measure |
Omega 3 Fatty Acids
n=46 Participants
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
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
|
Corn Oil
n=45 Participants
Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement
|
|---|---|---|
|
Change in Pulse Wave Velocity at 12 Weeks of Intervention
baseline
|
9.8 m/s
Interval 8.1 to 10.6
|
9.3 m/s
Interval 8.5 to 10.7
|
|
Change in Pulse Wave Velocity at 12 Weeks of Intervention
end of follow up
|
10.1 m/s
Interval 8.0 to 10.9
|
9.7 m/s
Interval 8.3 to 11.2
|
Adverse Events
Omega 3 Fatty Acids
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Corn Oil
Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omega 3 Fatty Acids
n=50 participants at risk
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
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
|
Corn Oil
n=50 participants at risk
Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement
|
|---|---|---|
|
Renal and urinary disorders
Started dialysis
|
4.0%
2/50 • Number of events 2 • Three months of follow up
|
4.0%
2/50 • Number of events 2 • Three months of follow up
|
|
Renal and urinary disorders
Hyperkalemia
|
0.00%
0/50 • Three months of follow up
|
2.0%
1/50 • Number of events 1 • Three months of follow up
|
|
Blood and lymphatic system disorders
Cervical mass
|
0.00%
0/50 • Three months of follow up
|
2.0%
1/50 • Number of events 1 • Three months of follow up
|
Other adverse events
| Measure |
Omega 3 Fatty Acids
n=50 participants at risk
Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
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
|
Corn Oil
n=50 participants at risk
Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement
|
|---|---|---|
|
Gastrointestinal disorders
Nausea, vomiting or diarrhea
|
28.0%
14/50 • Number of events 14 • Three months of follow up
|
24.0%
12/50 • Number of events 12 • Three months of follow up
|
|
Product Issues
Minor complaints
|
26.0%
13/50 • Number of events 13 • Three months of follow up
|
72.0%
36/50 • Number of events 36 • Three months of follow up
|
Additional Information
Dr. Francisco Perez Bravo, Director
Institute of Nutrition and Food Technology University of Chile
Phone: +5629781411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place