NCT Number: NCT02992548
Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty acids. Erythrocyte membrane oleic acid is significantly higher in patients with acute coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also be related to decreased oleic acid content of erythrocyte membrane. There is no report about the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are recognized as therapeutic agents for reducing triglycerides, statin may affect on the erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte membrane FA contents including oleic acid in CKD patients.
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Notify MeKey information
Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Dong-A University, Busan, South Korea
About this study
Patients with chronic kidney disease (CKD) have higher risk of death and cardiovascular disease than general population. Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty acids.
Omega-3 FA such as EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid), and EPA/arachidonic acid ratio are well known as key indicators of cardiovascular disease. In addition, erythrocyte membrane oleic acid is significantly higher in patients with acute coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also be related to decreased oleic acid content of erythrocyte membrane. There is no report about the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are recognized as therapeutic agents for reducing triglycerides, statin may affect on the erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte membrane FA contents including oleic acid in CKD patients.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- CKD patients who agreed with written informed consent
- CKD patients who do not take statin
- Who have LDL cholesterol over 100mg/dL and coronary vascular disease(CVD) or equivalent risk; Who have LDL cholesterol over 130mg/dL and two or more coronary vascular risk; Whose LDL cholesterol over 160mg/dL in patient with CKD stage 1 to 5 without dialysis.
Exclusion criteria
- Patients with acute illness, a history of active infection, CVD, acute kidney injury during the past 3 months, or a history of malignancy or liver disease
- Patients using statin, omega-3 fatty acid or sevelamer hydrochloride within 3 months
- Patients who experienced side effects by statin treatment
- Pregnant or pregnancy expected CKD patients
- Patient with dyslipidemia due to nephrotic syndrome
- Patient taken imaging study using contrast media during the past 14 days
- Patient with albumin level < 3.0 g/dL
Treatment and study plan
Primary outcomes
-
mean change of erythrocyte membrane fatty acid including oleic acid
Time frame: 24 weeks after intervention
Secondary outcomes
-
mean change of total cholesterol
Time frame: 24 weeks after intervention
-
mean change of triglyceride
Time frame: 24 weeks after intervention
-
mean change of LDL-cholesterol
Time frame: 24 weeks after intervention
-
mean change of HDL-cholesterol
Time frame: 24 weeks after intervention
-
mean change of adiponectin
Time frame: 24 weeks after intervention
Sponsors and collaborators
Lead sponsor
Dong-A University
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Dec 14, 2016
- Registry last updated
- Mar 11, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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