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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03982966
Acronym
CRF
Enrollment
60
Registered
2019-06-12
Start date
2019-01-01
Completion date
2020-05-01
Last updated
2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

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

Interventions

DIETARY_SUPPLEMENTOmega 3 fatty acids (fish oil) 1000 mg/day oral

Omega 3 fatty acids (fish oil) 1000 mg/day oral

Sponsors

Damanhour University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feutin-A Levelsix monthsvascular calcification biomarkers
Osteoprotegrinsix monthsvascular calcification biomarkers

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026