Trials / Completed
CompletedNCT03982966
Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With 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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Damanhour University · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Omega 3 fatty acids (fish oil) 1000 mg/day oral | Omega 3 fatty acids (fish oil) 1000 mg/day oral |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2020-04-30
- Completion
- 2020-05-01
- First posted
- 2019-06-12
- Last updated
- 2020-06-25
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03982966. Inclusion in this directory is not an endorsement.