Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

Inflammation Clinical Trial

Official title:

Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04900532
• Other study ID #: Denise Mafra
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 31, 2023
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hemodialysis
• Inflammation
• Kidney Diseases
• Microbiota
• Oxidative Stress
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Tocotrienol rich fraction
Supplementation with a Vitamin E compound.
• Placebo
Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.

Locations

Country	Name	City	State
Brazil	Denise Mafra	Rio de Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal Fluminense	Wayne State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in antioxidants and anti-inflammatory biomarkers	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	4 weeks
Secondary	Change in inflammatory biomarkers	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).	4 weeks