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

Primary Purpose

Chronic Renal Failure

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Chronic Renal Failure

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

al Mowassah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Omega 3

Control

Arm Description

Group 1 will be 40 patients that will take Omega 3 fatty acids (fish oil)

20 patients will not take omega 3 fatty acids.

Outcomes

Primary Outcome Measures

Feutin-A Level

vascular calcification biomarkers

Osteoprotegrin

vascular calcification biomarkers

Secondary Outcome Measures

Full Information

NCT ID

NCT03982966

First Posted

June 9, 2019

Last Updated

June 24, 2020

Sponsor

Damanhour University

1. Study Identification

Unique Protocol Identification Number

NCT03982966

Brief Title

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

Acronym

CRF

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Damanhour University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omega 3

Arm Type

Experimental

Arm Description

Group 1 will be 40 patients that will take Omega 3 fatty acids (fish oil)

Arm Title

Control

Arm Type

No Intervention

Arm Description

20 patients will not take omega 3 fatty acids.

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Feutin-A Level

Description

vascular calcification biomarkers

Time Frame

six months

Title

Osteoprotegrin

Description

vascular calcification biomarkers

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rehab H Werida, Lecturer

Organizational Affiliation

Clinical Pharmacy Lecturer

Official's Role

Study Chair

Facility Information:

Facility Name

al Mowassah Hospital

City

Alexandria

ZIP/Postal Code

21500

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15216492

Citation

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.

Results Reference

background

PubMed Identifier

19491380

Citation

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.

Results Reference

background

Learn more about this trial

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

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