Chronic Kidney Diseases, Hemodialysis, Inflammation, Microbiota, Oxidative Stress
Conditions
Brief summary
The objective of this study is to evaluate the supplementation with tocotrienol, a vitamin E compound on inflammation, oxidative stress, and microbiota on Chronic Kidney Disease patients.
Detailed description
In Chronic Kidney Disease (CKD), inflammation and oxidative stress are common statuses, which are aggravated by renal replacement therapy such as hemodialysis. Currently, intestinal microbiota imbalance has been associated with both inflammation and oxidative stress. In this regard, strategies in the management of this framework are necessary. It has been observed that vitamin E plays an important role in the modulation of transcription factors involved in inflammation such as NF-kB and Nrf2, acting on cell membrane protection and tissue recovery. Its benefits have been proven both in renal and intestinal health, however, studies analyzing the vitamin E supplementation in the modulation of intestinal microbiota with consequent effect on CKD and its reflexes are scarce. Thus, the current randomized, double-blind, placebo-controlled study will evaluate the effects of vitamin E supplementation on the modulation of the expression of nuclear cytokine (NF-kB e Nrf2), activators and inhibitors, as well as, on inflammation and oxidative stress and on the modulation of the intestinal microbiota in patients CKD.
Interventions
DIETARY_SUPPLEMENTTocotrienol rich fraction
Supplementation with a Vitamin E compound.
DIETARY_SUPPLEMENTPlacebo
Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.
Sponsors
Wayne State University
Universidade Federal Fluminense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic kidney disease * Aged from 18 to 60 years * Must be able to swallow capsules
Exclusion criteria
* Pregnant patients * Smokers * Using antibiotics in the last 3 months * Using antioxidant supplements in the last 3 months * Usual intake Autoimmune * Hemodialysis started less than 6 months for hemodialysis patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in antioxidants and anti-inflammatory biomarkers | 4 weeks | Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1). glutathione peroxidase (GPx), heme oxygenase-1 (HO-1) and microbiota composition from patients feces DNA uremic toxins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory biomarkers | 4 weeks | Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha). |
Countries
Brazil
Outcome results
None listed