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| Name | Class |
|---|---|
| Servicio de Salud Metropolitano Oriente | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega 3 fatty acids | Experimental | Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks |
|
| Corn oil | Placebo Comparator | Supplementation of 3.7 g of corn oil per day during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 fatty acids | Dietary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline and 12 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C Reactive Protein Levels at 12 Weeks of Intervention | Blood C reactive protein measured at baseline and the end of the intervention. | At baseline and 12 weeks of intervention |
| Change in Pulse Wave Velocity at 12 Weeks of Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutrition and Food Technology University of Chile | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21135888 | Background | 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. | |
| 27871238 | Background | Borg 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. |
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Sharing of information must be discussed with the sponsor
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | At baseline and 12 weeks of intervention |
|
Three months of follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Started dialysis | Renal and urinary disorders | Systematic Assessment | Started dialysis due to terminal renal failure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea, vomiting or diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco Perez Bravo, Director | Institute of Nutrition and Food Technology University of Chile | +5629781411 | fperez@inta.uchile.cl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2019 | Jul 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000419 | Albuminuria |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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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
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Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
| Corn oil | Dietary Supplement | Corn oil will be the placebo comparator for omega 3 fatty acids supplement |
|
Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s
| At baseline and 12 weeks of intervention |
| 28008943 | Background | Xu 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. |
| 25104273 | Background | Hoogeveen 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. |
| 27756237 | Background | Malhotra 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. |
| Withdrawal by Subject |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Urine albumin excretion | Median | Inter-Quartile Range | mg/g creatinine |
|
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | mg/L | At baseline and 12 weeks of intervention |
|
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | m/s | At baseline and 12 weeks of intervention |
|
|
|
|
| 0 |
| 50 |
| 2 |
| 50 |
| 27 |
| 50 |
| EG001 | 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 | 0 | 50 | 4 | 50 | 48 | 50 |
|
| Hyperkalemia | Renal and urinary disorders | Systematic Assessment |
|
| Cervical mass | Blood and lymphatic system disorders | Systematic Assessment | Cervical mass |
|
| Minor complaints | Product Issues | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |