Renal Insufficiency, Chronic Clinical Trial
Official title:
Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Verified date | July 2019 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 100 |
Est. completion date | October 31, 2018 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Chile | Institute of Nutrition and Food Technology University of Chile | Santiago | Metropolitana |
Lead Sponsor | Collaborator |
---|---|
University of Chile | Servicio de Salud Metropolitano Oriente |
Chile,
Borg M, Svensson M, Povlsen JV, Schmidt EB, Aalkjær 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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | At baseline and 12 weeks of intervention | |
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. | 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 | At baseline and 12 weeks of intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05056727 -
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
|
Phase 3 | |
Withdrawn |
NCT01655186 -
A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus
|
Phase 2 | |
Completed |
NCT03481686 -
Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
|
N/A | |
Active, not recruiting |
NCT03672110 -
Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen
|
Phase 3 | |
Enrolling by invitation |
NCT02237534 -
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
|
Phase 4 | |
Completed |
NCT02126293 -
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
|
Phase 3 | |
Terminated |
NCT01533545 -
Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients
|
N/A | |
Completed |
NCT04498156 -
Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)
|
||
Recruiting |
NCT04020328 -
Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency
|
Phase 4 | |
Recruiting |
NCT06366529 -
Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction
|
||
Active, not recruiting |
NCT04876963 -
HOLT-ED: Holter-monitoring in End-stage Renal Disease
|
||
Completed |
NCT03836508 -
Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis
|
N/A | |
Completed |
NCT03250715 -
Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure
|
N/A | |
Completed |
NCT03577249 -
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
|
Phase 2/Phase 3 | |
Completed |
NCT01975818 -
Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
|
Phase 2 | |
Active, not recruiting |
NCT05766644 -
App-based Education Program for CKD
|
N/A | |
Active, not recruiting |
NCT02791880 -
Acute Kidney Injury Genomics and Biomarkers in TAVR Study
|
||
Recruiting |
NCT02947750 -
Neurovascular Transduction During Exercise in Chronic Kidney Disease
|
Phase 2 | |
Terminated |
NCT02286258 -
Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)
|
Phase 1/Phase 2 | |
Completed |
NCT01711853 -
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
|
Phase 1 |