Status:
UNKNOWN
EVOO Coratina Intervention on Lipids in Non-diabetic Hypertensive Patients Undergoing Hemodialysis (EVOOC-3H)
Lead Sponsor:
Fondazione Schena
Collaborating Sponsors:
University of Bari
Conditions:
Chronic Kidney Disease Stage V
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Twenty-four non-diabetic hypertensive and hyperlipidemic patients undergoing periodic chronic hemodialysis will be enrolled for receiving extravirgin olive oil (EVOO) Coratina (12 patients) or refined...
Detailed Description
Detailed Description: EXTRAVIRGIN OLIVE OIL CORATINA INTERVENTION ON LIPIDS IN NON-DIABETIC HYPERTENSIVE (H) PATIENTS WITH HYPERLIPIDEMIA (H)UNDERGOING PERIODIC HEMODIALYSIS (H) (EVOOC-3H) INTRODUCTIO...
Eligibility Criteria
Inclusion
- The investigators will enroll non-diabetic hypertensive and hyperlipidemic patients undergoing chronic HD
- Hypertension will be defined as having a systolic blood pressure of \>130 mmHg and a diastolic blood pressure \>80 mmHg or having any antihypertensive agents.
- Hyperlipidemia will be defined as having LDL cholesterol values more than 100 mg/dl or receiving statins at any dose.
- Eligible patients may be of any age.
Exclusion
- Diabetes mellitus type 1 or 2
- Severe heart failure (NYHA class IV)
- Patients with low compliance or severe psychiatric illnesses
- Smoking, intake of antioxidant supplements (eg, carotenoids, vitamin C, vitamin E and glutathione), aspirin, or any other drug with established antioxidant properties, hyperlipidemia, obesity (body mass index \>30 kg/m2), diabetes, celiac or other intestinal disease, life-threatening
- Survival expectancy \<6 months based on managing physicians assessment
- Inability to participate in the trial based on managing physicians assessment
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03779529
Start Date
July 1 2018
End Date
December 31 2021
Last Update
December 7 2020
Active Locations (1)
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1
Fondazione Schena
Valenzano, Bari, Italy, 70010