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

D

Damanhour University

Status

Completed

Conditions

Chronic Renal Failure

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03982966
omega 3 fatty acids on CRF

Details and patient eligibility

About

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

Full 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

Enrollment

60 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Omega 3
Experimental group
Description:
Group 1 will be 40 patients that will take Omega 3 fatty acids (fish oil)
Treatment:
Dietary Supplement: Omega 3 fatty acids (fish oil) 1000 mg/day oral
Control
No Intervention group
Description:
20 patients will not take omega 3 fatty acids.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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