Dietary intervention with octacosanol & vitamin K2 supplement on lipid profile, oxidative stress and inflammation in patients on atorvastatin therapy
- Conditions
- hypercholesterolemiamixed dyslipidemiaCardiovascular - Coronary heart diseaseCardiovascular - HypertensionMetabolic and Endocrine - Metabolic disorders
- Registration Number
- ACTRN12619000102178
- Lead Sponsor
- Ivan Stankovic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 88
Confirmed diagnosis of hypercholesterolemia or mixed dyslipidemia
The use of atorvastatin (20 mg/day) for minimum 4 months prior to the study entry
BMI: 18 - 35 kg/m2
triglycerides serum levels above 5.6 mmol/L, previous acute coronary syndrome within 1 month, serious heart failure, cerebral vascular disease, history of severe infections, known hypersensivity to any of the ingredients of the formulation, currently receiving agents with potential to interact with octacosanol, recent or chronic use of oral anticoagulant drugs and anticipated compliance problems. Significant pre-existing diseases including cancer, liver and/or renal insufficiency, psychiatric disorders, systematic inflammatory or autoimmune disease. In addition, patients with one of the following laboratory values above 3 times the upper limit of normal laboratory range: serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), and creatine phosphokinase (CK) above 5 times the upper limit of normal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum PCSK9 level ( ELISA method recognizes free and LDL-R bound PCSK9 in the same time, this is composite primary outcome)[Baseline (visit 1), at 8 weeks (visit 2) and 13 weeks (visit 3, endpoint)]
- Secondary Outcome Measures
Name Time Method