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

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

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Dietary supplement: Omega 3 fatty acids (fish oil) 1000 mg/day oral

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21500
    • al Mowassah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega 3; 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; Omega 3 fatty acids (fish oil) 1000 mg/day oral
No Intervention: Control; 20 patients will not take omega 3 fatty acids.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Damanhour University
• Investigators: Study Chair: Rehab H Werida, Lecturer, Clinical Pharmacy Lecturer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: June 9, 2019
• First Submitted That Met QC Criteria: June 9, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Calcium Metabolism Disorders; Calcinosis; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Vascular Calcification
• Other Study ID Numbers: omega 3 fatty acids on CRF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No