Clinical trial NCT03982966: Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Feutin-A Level
timeFrame: six months
measure: Osteoprotegrin
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: al Mowassah Hospital
Study officials:
affiliation: Clinical Pharmacy Lecturer
name: Rehab H Werida, Lecturer
role: STUDY_CHAIR
References:
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.
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.