Renal Insufficiency, Chronic
Conditions
Keywords
Albuminuria, Carotid Intima-Media Thickness, Pulse Wave Velocity, Inflammation
Brief 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
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: 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
Interventions
DIETARY_SUPPLEMENTOmega 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
DIETARY_SUPPLEMENTCorn oil
Corn oil will be the placebo comparator for omega 3 fatty acids supplement
Sponsors
Servicio de Salud Metropolitano Oriente
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Urine Albumin Excretion Decrease of 20% or More | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in C Reactive Protein Levels at 12 Weeks of Intervention | At baseline and 12 weeks of intervention | Blood C reactive protein measured at baseline and the end of the intervention. |
| Change in Pulse Wave Velocity at 12 Weeks of Intervention | At baseline and 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 |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Corn Oil | Total | Omega 3 Fatty Acids |
|---|---|---|---|
| Age, Continuous | 66 years | 66 years | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 100 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Chile | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 26 Participants | 49 Participants | 23 Participants |
| Sex: Female, Male Male | 24 Participants | 51 Participants | 27 Participants |
| Urine albumin excretion | 541 mg/g creatinine | 455 mg/g creatinine | 363 mg/g creatinine |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 27 / 50 | 48 / 50 |
| serious Total, serious adverse events | 2 / 50 | 4 / 50 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omega 3 Fatty Acids | Number of Participants With a Urine Albumin Excretion Decrease of 20% or More | 19 Participants |
| Corn Oil | Number of Participants With a Urine Albumin Excretion Decrease of 20% or More | 13 Participants |
Comparison: A Fisher exact test was performedp-value: 0.257Fisher Exact
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Omega 3 Fatty Acids | Change in C Reactive Protein Levels at 12 Weeks of Intervention | baseline | 3.3 mg/L |
| Omega 3 Fatty Acids | Change in C Reactive Protein Levels at 12 Weeks of Intervention | end of follow up | 2.1 mg/L |
| Corn Oil | Change in C Reactive Protein Levels at 12 Weeks of Intervention | baseline | 1.7 mg/L |
| Corn Oil | Change in C Reactive Protein Levels at 12 Weeks of Intervention | end of follow up | 1.9 mg/L |
Comparison: A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groupsp-value: 0.231Fisher Exact
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Omega 3 Fatty Acids | Change in Pulse Wave Velocity at 12 Weeks of Intervention | baseline | 9.8 m/s |
| Omega 3 Fatty Acids | Change in Pulse Wave Velocity at 12 Weeks of Intervention | end of follow up | 10.1 m/s |
| Corn Oil | Change in Pulse Wave Velocity at 12 Weeks of Intervention | baseline | 9.3 m/s |
| Corn Oil | Change in Pulse Wave Velocity at 12 Weeks of Intervention | end of follow up | 9.7 m/s |
Comparison: A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groupsp-value: 0.043Mixed Models Analysis