Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With CRF

Study Overview
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Brief Summary
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study the effect of omega 3fatty acids on the vascular calcification biomarkers Fetuin -A and Osteoprotegerin (OPG) in dialysis patients.

Detailed Description
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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

Official Title
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The Effect of the of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With Chronic Renal Failure Undergoing Hemodialysis.

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Dietary Supplement: Omega 3 fatty acids (fish oil) 1000 mg/day oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 hemodialysis patients, (20-80) years old. Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at least 6 months). 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 served as control will not take omega 3 fatty acids.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3<br>Group 1 will be 40 patients that will take Omega 3 fatty acids (fish oil) | Dietary Supplement: Omega 3 fatty acids (fish oil) 1000 mg/day oral<br>* Omega 3 fatty acids (fish oil) 1000 mg/day oral<br>|
| No Intervention: Control<br>20 patients will not take omega 3 fatty acids. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feutin-A Level | vascular calcification biomarkers | six months | 
| Osteoprotegrin | vascular calcification biomarkers | six months |