Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With CRF
NCT ID: NCT03982966
Last Updated: 2020-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-01-01
2020-05-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Omega 3
Group 1 will be 40 patients that will take Omega 3 fatty acids (fish oil)
Omega 3 fatty acids (fish oil) 1000 mg/day oral
Omega 3 fatty acids (fish oil) 1000 mg/day oral
Control
20 patients will not take omega 3 fatty acids.
No interventions assigned to this group
Interventions
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Omega 3 fatty acids (fish oil) 1000 mg/day oral
Omega 3 fatty acids (fish oil) 1000 mg/day oral
Eligibility Criteria
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Inclusion Criteria
* Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at least 6 months).
Exclusion Criteria
20 Years
80 Years
ALL
No
Sponsors
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Damanhour University
OTHER
Responsible Party
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Rehab Werida
Clinical Pharmacy Lecturer
Principal Investigators
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Rehab H Werida, Lecturer
Role: STUDY_CHAIR
Clinical Pharmacy Lecturer
Locations
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al Mowassah Hospital
Alexandria, , Egypt
Countries
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References
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London GM, Marchais SJ, Guerin AP. Arterial stiffness and function in end-stage renal disease. Adv Chronic Kidney Dis. 2004 Apr;11(2):202-9. doi: 10.1053/j.arrt.2004.02.008.
Sigrist MK, Levin A, Er L, McIntyre CW. Elevated osteoprotegerin is associated with all-cause mortality in CKD stage 4 and 5 patients in addition to vascular calcification. Nephrol Dial Transplant. 2009 Oct;24(10):3157-62. doi: 10.1093/ndt/gfp253. Epub 2009 Jun 2.
Other Identifiers
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omega 3 fatty acids on CRF
Identifier Type: -
Identifier Source: org_study_id
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