Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

Not Applicable

Completed

• Conditions: Inflammation; Oxidative Stress; Chronic Kidney Diseases; Microbiota; Hemodialysis
• Interventions: Dietary Supplement: Tocotrienol rich fraction; Dietary Supplement: Placebo

• Registration Number: NCT04900532
• Lead Sponsor: Universidade Federal Fluminense

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.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-08-01
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-25
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Effects of supplementation with tocotrienol on chronic kidney disease patients	Tocotrienol rich fraction	Administration of tocotrienol-rich-fraction (TRF) capsules, containing 360mg of tocotrienol and 80mg of tocopherol twice a day for six months.
Effects of supplementation with tocotrienol on lipid profile of chronic kidney disease patients	Placebo	Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio de Janeiro, RJ, Brazil