Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2025-12-28 @ 3:56 PM
Study NCT ID:
NCT03982966
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2019-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With CRF
Sponsor:
Damanhour University
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRF
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: