Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With CRF
- Conditions
- Chronic Renal Failure
- Registration Number
- NCT03982966
- Lead Sponsor
- Damanhour University
- Brief Summary
study the effect of omega 3fatty acids on the vascular calcification biomarkers Fetuin -A and Osteoprotegerin (OPG) in dialysis patients.
- Detailed Description
2-All Participants agreed to take part in this clinical research and provide informed consent.
3-Patients undergo both undergo hemodialysis (HD) will be enrolled from dialysis unit in al Moussa Hospital Alexandria.
4-Serum samples will be collected for measuring the biomarkers. 5-Our design is randomized, controlled, open-intervention study. 6- All enrolled patients will be divided into 2 groups, Group 1 will be 40 patients that will take omega 3fatty acids and Group 2 will be 20 patients will not take omega 3 fatty acids.
7-All patients will be followed up during 6 months' period. 8-Statsicial tests appropriate to the study design will be conducted to evaluate the significance of the results.
9-Measuring outcome: the primary outcome is the increase of the serum levels of the vascular calcification biomarkers after 6months.
10-Results, conclusions, discussion and recommendations will be given.
Inclusion criteria:
* 60 hemodialysis patients, (20-80) years old.
* Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at least 6months).
Exclusion Criteria:
People with active infections (fever or any evidence of infections), known malignancy, connective tissue disorders, immunosuppressive therapy, and inflammatory diseases, current use of warfarin ,history of fish oil/omega 3 allergies were excluded.
Methodology:
* Feutin-A and Osteoprotegrin (OPG) will be determined by ELISA.
* Serum lipid levels, phosphorus, calcium, Parathormone (i-PTH), alkaline phosphatase, albumin and creatine levels.
* BMI
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 60 hemodialysis patients, (20-80) years old.
- Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at least 6 months).
- People with active infections (fever or any evidence of infections), known malignancy, connective tissue disorders, immunosuppressive therapy, and inflammatory diseases, current use of warfarin ,history of fish oil/omega 3 allergies were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Osteoprotegrin six months vascular calcification biomarkers
Feutin-A Level six months vascular calcification biomarkers
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
al Mowassah Hospital
🇪🇬Alexandria, Egypt
al Mowassah Hospital🇪🇬Alexandria, Egypt