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Completed

NCT Number: NCT03982966

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

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

Primary outcomes

  1. Feutin-A Level

    Time frame: six months

    vascular calcification biomarkers

  2. Osteoprotegrin

    Time frame: six months

    vascular calcification biomarkers

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study title

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.

Acronym: CRF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2019
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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