Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With CRF
Ключови думи
Резюме
Описание
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
Дати
Последна проверка: | 05/31/2020 |
Първо изпратено: | 06/08/2019 |
Очаквано записване подадено: | 06/08/2019 |
Първо публикувано: | 06/11/2019 |
Изпратена последна актуализация: | 06/23/2020 |
Последна актуализация публикувана: | 06/24/2020 |
Действителна начална дата на проучването: | 12/31/2018 |
Приблизителна дата на първично завършване: | 04/29/2020 |
Очаквана дата на завършване на проучването: | 04/30/2020 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Omega 3
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: Omega 3 Group 1 will be 40 patients that will take Omega 3 fatty acids (fish oil) | Dietary Supplement: Omega 3 Omega 3 fatty acids (fish oil) 1000 mg/day oral |
No Intervention: Control 20 patients will not take omega 3 fatty acids. |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 20 Years Да се 20 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | 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. |
Резултат
Първични изходни мерки
1. Feutin-A Level [six months]
2. Osteoprotegrin [six months]