Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Ключови думи
Резюме
Описание
In a double blind trial in patients with chronic renal disease, the effects of a 3.7 g supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of corn oil during 12 weeks, will be assessed on the following parameters:
1. Urine albumin excretion
2. Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin
3. Carotid intima media thickness and pulse wave velocity
4. Inflammation status assessed measuring serum levels of C reactive protein and interleukin 6
5. Metabolic control of diabetes
6. Serum lipid levels
Дати
| Последна проверка: | 06/30/2019 |
| Първо изпратено: | 08/07/2017 |
| Очаквано записване подадено: | 09/10/2017 |
| Първо публикувано: | 09/11/2017 |
| Изпратена последна актуализация: | 07/29/2019 |
| Последна актуализация публикувана: | 09/08/2019 |
| Дата на първите подадени резултати: | 03/28/2019 |
| Дата на първите подадени резултати от QC: | 07/29/2019 |
| Дата на първите публикувани резултати: | 09/08/2019 |
| Действителна начална дата на проучването: | 09/19/2017 |
| Приблизителна дата на първично завършване: | 10/30/2018 |
| Очаквана дата на завършване на проучването: | 10/30/2018 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Omega 3 fatty acids
Dietary Supplement: Corn oil
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Omega 3 fatty acids Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks | Dietary Supplement: Omega 3 fatty acids Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids |
| Placebo Comparator: Corn oil Supplementation of 3.7 g of corn oil per day during 12 weeks | Dietary Supplement: Corn oil Corn oil will be the placebo comparator for omega 3 fatty acids supplement |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Urinary albumin excretion over 30 mg/g creatinin - Chronic renal failure stage 2 to 4 - Absence of serious conditions such as cáncer, decompensated heart failure, chronic infections and severe arterial lesions Exclusion Criteria: - Blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8% - Presence of cognitive impairment that does not allow to sigin a written informed consent - Alcohol or illicit drug abuse |
Резултат
Първични изходни мерки
1. Number of Participants With a Urine Albumin Excretion Decrease of 20% or More [At baseline and 12 weeks of intervention]
Вторични изходни мерки
1. Change in C Reactive Protein Levels at 12 Weeks of Intervention [At baseline and 12 weeks of intervention]
2. Change in Pulse Wave Velocity at 12 Weeks of Intervention [At baseline and 12 weeks of intervention]
