- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03982966
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Alexandria, Egypt, 21500
- al Mowassah Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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)
|
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
Time Frame: six months
|
vascular calcification biomarkers
|
six months
|
Osteoprotegrin
Time Frame: six months
|
vascular calcification biomarkers
|
six months
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- omega 3 fatty acids on CRF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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